Herbal Medicine Revisited 2/4
Earlier blogs have examined the use of surveys as research tools to delineate prevalence estimates and to examine its associated demographic variables and correlates among HM users that reside in urban metropolis of Ghana. Addition of Consumer Satisfaction (CS) survey to such a study is argued in Blog ¼ to possibly yield important information that may be useful in formulation content enhancements and may be beneficial in generating labeling improvements and ultimately, in enhancing the provision of better treatment outcomes for urban HM users.
Legibly written and clearly stated package labels and package leaflets that are accurate and comprehensive and scientifically supported will generate better-informed, more health literate patients/users who are amply informed about the risk-benefit ratio consistent with the formulation of choice for their health needs. But current package labeling and its associated use instructions are deficient in details. Package leaflets are usually unavailable. Are the HM package labeling user-friendly? Can users with a minimal level of health and general literacy understand the directions for use of formulation on the packaging? Do the packaging instructions have underlying science bases?
Improvement in formulation labeling will have to address these questions as a prelude to initiating improvements in consumer knowledge base/status for enhanced use decision–making and enhanced HM use experience. As a direct consequence, current inadequate labeling constitutes health hazards and represents indelible blemishes on HM’s relentless drive towards a modernity imbued with a science base. Nevertheless, the undeniable appeal of HM is so durable that it has withstood the negative impact of observed labeling deficiencies and this durability has often stymied broad-based efforts by stakeholder to reconfigure HM into a more viable broad-based alternative to Allopathic medicine (AM). As user acceptance of current defects in labeling becomes normalized, such prevalent cultural norms will undercut regulatory efforts to instill among provider populations good labeling practices and package leaflets that accurately present formulation content and informs and instills in users a good HM use culture. In this blog, the thoroughness of formulation package labelling is examined as addendums to provider adaptations to altered cultural settings.
Labels on HM formulations are intended to specify the molecular chemical composition of a formulation, provide an inventory of its active chemical constituent(s) and stipulate a discrete set of use information that encompasses: the dose regimen, the directions for optimal use, the storage conditions, the contraindications and the possible adverse side effects triggered by the formulation. Together, this array of essential information constitute a crucial part of formulation awareness creation and are instrumental in bringing clarity to use intentions and in conveying, with firmness, user expectations of therapeutic value to be derived from formulation. Users can deduce from labels their individual prospects of achieving and improving their health-related quality of life objectives with the specific formulation of choice.
Exhaustive formulation label should, therefore, improve the content of the pharmacological information to enable users to either optimally cement or ideally loosen their decisional preferences for certain formulations. Comprehensive labeling will, inexorably, assist in the reduction of HM use adversities as critical information on contraindications (usually reported in package leaflet as an insert document) and on potential adverse side effects are revealed to users prior to the actual use of formulation.
Despite these manifest benefits offered by thorough labeling and the prominence of labeling as an issue of safety and of health literacy, anecdotal-based assessment shows that the number of nondescript labeling of packaged HM formulations is surprisingly high. Perfunctory instructions on dose and mode of administration as well as on the local or scientific names of key herbs are usually present on most labels on popular formulations. But some formulations do not bear any labels and others are missing an array of essential labeling information. Specific labeling deficiencies may take one or more of the following forms: non-disclosure of scientific names of active constituents; non-disclosure of the real identity of key herbs for ostensible patent protection reasons; non-disclosure of “secret” additives, including AM adulterants, that are added as additional efficacy boost ; inadvertent labeling errors that includes mis-identification of herbs (intentional or otherwise) or listing of the wrong part of the herbal plant (intentional or otherwise); non-disclosure of possible adverse side effect; non-disclosure of age-defined dose limits, no declaration of contraindication and no stipulation of shelf-life. Observed lapses in product labeling are not limited to a few branded formulations but remain consistent across different brands. Such labeling deficiencies partly originate from the deeply entrenched notion that considers HM formulation as food additives and this benign consideration means that HM formulations do not require the same rigorous standard of labeling as AM drugs does. For this and other reasons yet to be clearly identified, improvements in the depth and clarity of formulation labels have not kept pace with the massive improvement in the quality of the packaged HM products.
The consequences of observed labeling deficiencies are enormous. User knowledge status on the chemical composition of the formulations is compromised accentuating users’ inability to grasp their individualized likelihood of benefits from use. Unspecified contraindications and unstated identity of active constituents diminishes user comprehension of their individualized possibilities of succumbing to adverse health effect and renders a priori estimation of the formulations’ injurious potential an impossible task. Lack of specificity of producer recommended dosage leads to either an over-dose or under-dose and both incorrect scenarios threaten user health. Ultimately, inadequate labeling of ready-to-use formulations strips users of their basic informational support needs and renders the utility of the label for guidance in clinical care ineffectual.
As a consequence, user high approval of HM formulation discussed in earlier blogs may now appear contradictory to their best health-related self-interest and to their best judgment in good pharmacological-based health literacy. Observed high user approval of HM formulation therefore represents a central and unacknowledged dichotomy between user high enthusiasms for herbalism and obvious disregard of the critical shortcomings of its presentation. Perhaps the historical testimonies of safety and efficacy of specific herbs has diminished the salience of exhaustive and specific user informational needs and has lessened the relationship of labels to the development of a healthy use culture. And as cultural and regulatory attitudes toward exhaustive labeling become relaxed, the relevance and appropriateness of labels become questionable and its effectiveness become uncertain.
To re-state current package labels and package leaflets trends for emphasis, it needs reiteration that current labels on formulation packages disclose minimal information about formulation composition and under-inform users, specifically, about the contraindication of the formulations. Considered largely as food supplements by the FDB, no official regulation enforces detailed formulation content disclosure in labeling nor penalizes providers that are not in compliance of labeling or package leaflet inserts. As observed anecdotally, many formulation packages have incomplete labels that omit important details such as the identity of active ingredients; that are silent about contraindication and that skips adverse side effects of formulation that are key attributes necessary for the deduction of the pharmacological value and safety.
Unstated, users either tacitly acknowledge or erroneously assume that its natural origin deprives it of any adverse side effects. Other users accede to the potential existence of adverse side effects but consider them generally inconsequential to the achievement of their overall health related quality of life goals. Many users seem to be focused primarily on the prophylactic and therapeutic effects and as a consequence consider any adverse health effect as a collateral danger inherently and indispensably associated with HM use. This operative perceptual framework undergirds a cultural context that hampers effective legislation on HM labeling that mandates the dissemination of adverse health effects. An ostensibly AM stereotypes that holds that medications should have a complete set of testable biomedical background information on its mechanism of action and on its safety is openly challenged by Ghana’s HM industry. Current trends reveal the complexities, in the global community, of requesting HM formulations considered food additives to bear safety labels.
The discussed dichotomy of views reveals the deeper questions that are at play. Should providers be compelled by regulatory policy to undertake scientific tests that identifies key bioactive ingredients, reveals adverse side effects and highlights other potential safety issues including contraindications on all formulations prior to marketing? Will the enactment of regulations that strongly enforces safety dampen provider enthusiasm and inadvertently place a cap on the repertoire of available options? And what should be the role of regulators in the safety prioritization exercise? Minimally, acute and chronic toxicity tests as required addition to labels are emerging as fixtures on regulatory lists of prerequisites.
As earlier noted in previous blogs, the scientific basis for the proposition of mandatory labels lags behind the broader HM cultural understanding and acceptance of label accuracy and so appreciation for complete labeling is a work in progress. Whether comprehensive labeling (provision of full complement of constituent names and chemical identity, constituent’s putative target sites and formulation contraindications) will be achieved soon is uncertain.
A two-prong approach can be utilized to expedite god labeling: surveys and bench science. It has been argued by HM proponents that HM is not AM and should not be subject to the same regulations for labeling as AM drug. Debating the pros and cons of this position is beyond the scope of this blog. But future studies that focus on the formal assessment of current labeling for clinical care can utilize questionnaires and group interviews to: evaluate the impact of the content of current labels on user comprehension of directions of use; delineate user knowledge status of safety and to decipher user perceptional knowledge on the development of adverse health. Such a survey study can contribute to a broader understanding of mechanistic path that thoroughness and user comprehension of HM formulation labels take to influence the quality of HM-based health care delivery and to improve its associated therapeutic outcomes.
It needs to be reiterated that the financial, logistics and time demands for the conduct of underlying scientific research are substantial and its demands will overwhelm the capacity and the resolve of small-scale providers to even attempt a semblance of a scientific research as support base for their recommended dosage as well as to provide scientific credibility to their stated contraindication. Partly because of these reasons, Regulatory agencies apparently do not insist that labels bear the names or chemical identity of formulation constituents because the time, resources and expertise needed for constituent identification is obviously beyond the means of all providers. But without formulation chemical contents, the FDB and consumers are obviously operating on an information vacuum that is partly offset by settling on the broad phytochemical grouping or scientific name of the plant instead of names of individual chemical entities whose putative bioactivities trigger observed efficacy.
Labeling deficiencies discussed above are noteworthy not only because they represent lack of regulatory control over provider activities, but because they constitute safety hazards and represent indelible blemishes on HM’s relentless drive towards modernity and towards wider acceptability. It needs no emphasis that stronger regulation and more active regulatory authority is needed to enforce good labeling. Regulatory enforcement for the completeness of labels should come directly under the national health spotlight with the FDB insisting on improvement in parts of the current guidelines that are deficient.
The FDB must also stimulate health debates with the underlying goal of the furnishing of complete labels for ready-to-use HM formulations. Health advocacy groups and regulatory authorities can encourage provider improvement on the provision of informational content on formulation packages. To find out user informational needs on formulations, a unique collaboration of clinical researchers and stakeholder research organizations can survey users and communicate respondent information to providers through the use of diverse social media platforms. User-entered comments in survey interviews can be analyzed by providers to tease out detailed and specific user thoughts on their informational needs and user preferences on labeling content of HM formulations.
Stakeholder advocacy can also encourage provider investment in the conduct of research that focus on the identification of the chemical structures of all active ingredients and that subsequently facilitates user accessibility to such pertinent scientific information prior to the concretization of their HM use intentions. Public health advocacy can subsequently empower users to be active seekers of pharmacological knowledge on the chemical constituents of formulation as a prelude to formulating an understanding of the constituents’ putative mechanistic role in disease attenuation.
Future exploratory study can examine whether credible contraindications (in package leaflet insert) and the inscription of warnings/precautions on labels can be an effective deterrent to abuse and an effective modifier of risky use behaviors particularly for alcohol-based bitters. Additional future studies can evaluate the details of labeling focusing on thoroughness, legibility and understandability and assess fully the impact of labeling on herbal medicine use intentions of new/regular HM formulation users. Researchers can re-assess labels in its current form for user accessibility and for user comprehension, for overall label comprehensiveness and for completeness of needed information. Label thoroughness can then be correlated with user satisfaction with its utility and with user improvement in the practice of safe HM use culture. Ultimately, several future studies can assess labeling impact on the improvement in user's knowledge of therapeutic efficacy and on user knowledge status of potential adverse health risks, on use attitudinal and use cultural changes and on user satisfaction with their HM use experience.