By Godwin Y. Agboka
ABSTRACT
Purpose: With a focus on patient safety in the marketing and use of non-prescription traditional herbal medicines (THMs), this article reports the findings of an analysis of documentation practices associated with 15 sampled THMs (nine labeled and six unlabeled) selected from stores, pharmaceutical shops, buses, traditional clinics, and streets of Ghana. The article is based on the fundamental assumption that THMs, much like conventional drugs, have side effects or toxic components, and therefore require effective documentation to alert users.
Method: The article employs the purposive sampling strategy of critical case sampling to analyze the 15 THM samples. This approach allowed me to select information-rich cases. These cases shed light on the challenges of labeling THMs and how those challenges impact patient safety. Using these cases, I made logical generalizations based on the outcomes of the analysis of the data.
Results: My observations revealed that some manufacturers made few attempts to provide information about the importance of pre-existing medical conditions, contraindications, period of use, who to contact or how to respond in case of overdose or adverse reactions, detailed dosage instructions, side effects, and potential drug interactions.
Conclusion: Although medical and health communication is a growing area in the field of technical communication, the specific topic of patient safety as it relates to THM documentation remains underexplored. Moreover, the relationship between patient safety and THMs is an important aspect of the healthcare needs for many people, and therefore deserves more attention.
Keywords: patient safety, developing nations, documentation, traditional herbal medicine, user advocacy
Practitioner’s Takeaway:
- Documentation issues surrounding non-conventional pharmaceutical products, such as THMs, intersect with technical communication in the areas of information accessibility, health communication, and document design.
- Not only must documentation designers of herbal medicine provide labels, but they must also facilitate learning and action by users.
- Effective container labels, package inserts, and high-quality oral communication and counseling from trained vendors can go a long way to address patient safety issues.
- THM users will have better value for their investment in THM products if technical communicators design documentation.
- Because different cultures have unique requirements, more research is necessary to replicate the present results and determine culture-specific guidelines for THM labeling.
INTRODUCTION
A growing number of patients are taking control of their healthcare needs and have increasingly embraced alternative medicine as a route to disease prevention and treatment. Although conventional approaches remain popular, alternative medicine provides “an important healthcare service whether people have physical or financial access to allopathic medicine” (Wachtel-Galor & Benzie, 2011, p. 1). A typical trend is the growing reliance on and use of traditional herbal medicines (THMs) in primary healthcare decisions. However, an often underreported or overlooked component of the utilization of THMs is patient safety as it relates to labeling and documentation practices. Historically, THMs have been a specialty of the informal economy and the work of mostly traditional medicine practitioners whose instructions are communicated orally—so the issue of formal, printed labels has been a recent phenomenon as THMs become increasingly formalized. More so, the question of effective and user-centered product documentation associated with THMs has not been explored.
Ultimately, very limited published, scholarly research has documented the labeling issues associated with THMs and their related adverse events (see Boadu & Asase, 2017). I found no scholarship in the field of technical communication that addresses THM documentation. This is surprising because technical communication is a cross-disciplinary field that overlaps with instructional design, health communication, information accessibility, and usability. Developing targeted information products for users has long been the core of technical communication work (Lauer & Brumberger, 2016). In fact, with their longstanding user advocacy role, technical communicators have a more nuanced knowledge and appreciation of the communication, cultural, and design issues that inform effective documentation (Johnson et al., 2007; Potts, 2014), and therefore should be at the front line of effective access to and use of THMs—an important healthcare resource for users. More specifically, in organizational contexts, technical communicators add value to product design and documentation by improving productivity, increasing user satisfaction, and providing quality at a cheaper cost (I return to this argument fully later in this article).
With a focus on patient safety in the marketing and use of non-prescription THMs and also using the purposive sampling strategy of critical case sampling, this article reports the findings of an analysis of documentation practices associated with 15 THMs drawn from stores, pharmacies, buses, traditional clinics, and streets of post-colonial Ghana. This article is based on the fundamental assumption that THMs, much like conventional drugs, have components that create adverse side effects, including toxicity (Canter & Ernest, 2004; Gouws, 2018), and therefore require effective documentation regarding their administration. In Ghana, for example, although the Ghanaian Food and Drugs Administration (FDA) publishes laws and regulations requiring labeling of medicinal products (see Figures 1 and 2), manufacturers circumvent these processes and market products with no or poor documentation. Two observations become evident from the analysis: (i) lack of or ineffective labeling of THM containers based on users’ and vendors’ assumption that THMs are “natural and safe”; and (ii) the need for effective technical communication in THM labeling practices, particularly in the contexts of developing countries.
The study has some limitations. First, interviews with patrons of THM vendors would have added rich perspectives to the study, but time constraints made this impossible. Moreover, the sample size was small; nonetheless, it still provides important preliminary insights into some of the broad challenges associated with the marketing and use of THMs and also points technical communicators to future areas of research.
Product Documentation and Patient Safety
Effective documentation accompanying medicinal products and patient safety have clear connections to product usability and health. Thus, providing accessible and functional communication about a product enables users to make smart and important decisions about their health. For many patients, medicine documentation is one of the most important, if not the only, instructional document they will have to effectively administer their medicines.
Essentially, poor documentation, or lack thereof, may impact patient health and safety.
Documentation is a descriptive extension of a product that can transform a user’s experience in positive or negative ways (Hogan, 2013, p. 156), depending on the developer’s efforts and understanding of the product, audience, and the context of use. It involves information products that accompany technology, software, and scientific products that users access for their activities. It may include all the marketing materials and all documentation that is produced during the research and development stage in addition to the support materials that are made available upon purchase of that product (Ahlberg, 2017, p. 8). Although it is not a primary product purchased by users, as a secondary product, documentation provides essential support for primary products (Smart, et al., 1996, p. 157). For example, documentation could point users to: (i) product features and instructions for using the product in the most appropriate way, (ii) useful information about the safety issues associated with the use of the product, and (iii) target audiences and how the documentation delivers information to those audiences. Effective documentation transmits information and also articulates the usability processes with all their potential benefits and risks (Slack, 2003, p. 1).The goal of documenting product information is to “honestly and clearly inform…users of all safety precautions and the extent to which they should be considered” (Klebanov, 2009, p. 6).
In many ways, documentation enables or empowers users. Consequently, it must be accurate, culturally appropriate, informative, and clear, because omissions may lead to serious consequences (Hogan, 2013). As Klebanov (2009) argues, although documentation may not be vital to the use of a product in every case and for all users, “proper documentation can mean the difference between life and death” (p. 6). For example, the often-cited Challenger Disaster case used in many technical communication classes is a typical case of information failure, ineffective documentation, or misunderstanding between developers and end-users, which resulted in the death of seven crew members. The precise delivery mode of information products varies for every product, but it should succeed in helping the user meet the specific expectations for the product, without injuring the user.
Ultimately, documentation has the potential to impact patient safety. In the specific context of this article, documentation practices associated with herbal medicines—in fact, any pharmaceutical products—are an important measure of patient safety. For example, a 2006 report released by the Institute of Medicine (IOM) suggests that problems with labeling were cited as the most common cause of outpatient medication errors and adverse drug effects (as cited in Veronin, 2011, p. 10). Poor labeling practices have also been cited as one of the leading causes of medication-related mortality globally (Jeetu & Girish, 2010), making quality control of product labels take on greater importance. I should note that patient safety used here encompasses the actions and processes which healthcare systems and organizations take to protect their patients from errors, accidents, infections, and injuries. It includes effective management and administration of medical resources in ways that safeguard the health of patients.
The Global Rise of THMs
THMs encompass “practices, approaches, knowledge and beliefs not based on scientific evidence that are applied to treat, diagnose and prevent illness within a society” (Moreira et al., 2014, p. 248). They are inextricably linked to indigenous cultural practices that reflect the historical, environmental, political, and economic conditions of indigenous people. THMs are “the most economical and available system of healthcare for a large number of [people] in rural and semi-rural areas” (Kamsu-Foguem & Foguem, 2014, p. 127). Not only are they the only option for healthcare or the most accessible option, but they have also become the preferred option (Twumasi, 2005). Studies report that THMs remain the foundation of about 25% of all synthetic drugs prescribed globally (Sahoo et al., 2010; Okigbo & Mmeka, 2006)—many of which are used in the treatment of heart disease, blood pressure regulation, pain, and asthma. They are taken and used in different formats: whole herbs, teas, syrup, essential oils, salves, rubs, capsules, and tablets (Wachtel-Galor & Benzie, 2011), and they are used in the prevention and treatment of multiple health conditions, including weight loss, health promotion, and therapy for chronic conditions. The primary reasons for their use are affordability, access, alignment with cultural beliefs, and assumptions about safety. However, while many benefits can be derived, research points to many negative outcomes as well (Gouws, 2018). The foundational argument motivating the use of THMs is the perception that they are “natural and safe” and therefore not toxic; however, this is inaccurate (Canter & Ernest, 2004). To quote Kamsu-Foguem & Foguem (2014), “Any substance with a healing influence can also generate unwanted or adverse side-effects . . . [that] . . . carry with them specific risk factors which can lead to increased vulnerability to human health difficulties” (p. 127). THMs reportedly have as many side effects or as much toxicity as biomedical drugs used in conventional contexts and may cause significant adverse events. For example, research published by the American Association of Poison Control Centers (AAPCC) based on 26 years of data (i.e., 1983–2009) and a reported 2 million plant ingestion exposures, suggests that only 18.5% of THMs were categorized as nontoxic (Carmona & Peirera, 2013). Moreover, the actual dosage and composition of THMs are mostly shrouded in secrecy, raising potential patient safety issues.
In the following sections, I share information about the context of the research, methods employed, samples used for the analysis, and results. I also discuss the implications of the findings, and ultimately make the case that because of their direct link to safety, technical communicators are better placed to design medicinal documentation.
RESEARCH STUDY PRESENTATION
Context of the Research: Ghana
Ghana is a post-colonial democracy inhabited by people of African descent. The official language of trade and education in Ghana is English (Owu-Ewie, 2006, p. 76), even though it has about 72 “living languages” (Zorc , 2003, p. 7). According to UNESCO’s Institute for Statistics (2018), the literacy rate in Ghana is 79%, although the breakdown in terms of age division tells a more nuanced story for the purposes of this study: 15–24 years (92.5), 15 years and above (79%), and 65 years and older (50.9%). As of 2017, 16.2% of the population had a college education, and national policy mandates that all communication that supports product manufactured in Ghana or abroad should be in English. Ghana’s economy itself is heavily dominated by the informal sector, which is made up of self-employed people such as manufacturers of local products, farmers, traders, food processors, artisans, and craft-workers who have limited structure or coordination. Much of this sector is greatly influenced by tradition.
THMs fall in this informal, traditional sector, and are a primary healthcare option for many Ghanaians of diverse educational, religious, socio-cultural, gender, age, and ethnic groups. They are a culturally acceptable healthcare option that has become universal in all parts of the country. Between 70% and 75% of the population depend on THMs for their primary healthcare, and THMs are also the primary form of treatment for more than 60% of children with high fever resulting from malaria (WHO, 2003a). THMs have often been used in the treatment of malaria, infertility, boils, asthma, hypertension, diabetes, stroke, cancer, and minor injuries (Darko, 2009). In some rural areas, they are the only available healthcare or the most preferred treatment options. Even in urban centers such as Accra, the capital, the sale and use of THMs have surged over the years (Darko, 2009); THMs are sold on the streets and in buses, pharmacies, stores, and traditional medicine clinics.
Their popularity is evident in their integration into mainstream healthcare. In 2012, the government of Ghana established the Traditional Medicine Practice Council (TMPC), after which THM practice was formally integrated into the main healthcare delivery system. In the past, the use of THMs was the preserve of unlicensed traditional practitioners; these practitioners claimed knowledge of the practice that was passed down from ancestors; however, presently trained THM practitioners are now licensed by the Kwame Nkrumah University of Science and Technology (KNUST), the Centre for Research into Plant Medicine, and the Tetteh Quarshie Memorial Hospital to consult and prescribe THMs for clients in both government and private hospitals (Agyei-Baffour et al., 2017).
Unfortunately, the regulation of THMs remains a major problem in Ghana. The Ghanaian Food and Drugs Authority (FDA) is the regulating body, but it has been unsuccessful in registering all THM healthcare centers or their products. Some manufacturing firms have circumvented the approval processes and managed to market their products, often making claims that may not be supported with evidence. Ghana’s Public Health Act, 2012 (ACT 851) section 118, mandates the Ghanaian FDA to regulate medicinal products by ensuring adequate and effective standards for products. Manufacturers who plan to market and prescribe medicinal products must satisfy requirements related to product content and labeling (see Figure 1).
In many cases, products go through the approval process, and then some are adulterated after registration. As a result, during post-surveillance activities by the Ghanaian FDA, some products have been recalled or banned from the market. At a stakeholders’ meeting in 2017, for example, the Chief Executive Officer of the Ghanaian FDA noted that no THM in the country had been able to go through the Ghanaian FDA clinical trial required to ascertain the efficacy of herbal preparation for the treatment of chronic diseases in the last five years (Kale-Dery, 2017, para. 1). Issues such as this have implications for the practice of technical communication. As professionals who are at the frontline of advocating for users and enhancing access to complex data, health services, and new discoveries, technical communicators have important roles to play in facilitating users’ access to quality design and information.
The Ghanaian FDA’s Labelling Guidelines
For the purposes of this study, the labeling of THMs is the primary concern. Legally, the Ghanaian FDA mandates that all THM products meet labeling requirements (see Figure 2) that are in agreement with the general guidelines published by the World Health Organization.
Labeling is a complex art that involves thoughtful investment of economic and human resources to facilitate quality and safety. Best practices in labeling require the dedication of sometimes entire technical communication departments or teams focused on the design, communication, and management of information either printed on or included in products. In Ghana, however, most pharmaceutical and manufacturing companies do not have technical communication departments, so the labeling of medicinal products is mainly left to untrained personnel who have to communicate the complex processes involved in the administration of medicines. They may decide what goes into labels and what forms labels should take; ultimately, the quality control and value to the user are compromised. Needless to say, poor labeling and packaging practices are major concerns (Vickers et al., 2006). Considering these patient safety issues, the present study sought to analyze some labels that accompany THMs sold across pharmacies, stores, buses, streets, and traditional healthcare centers in Ghana. The purpose was to ascertain how the labels met the Ghanaian FDA labeling requirements and address patient safety concerns.
METHODS
Design
Motivated by an exploratory qualitative data collection approach, I employed the purposive sampling strategy of critical case sampling to allow me to select information-rich cases (Patton, 1990, p. 169) whose study and analysis shed light on the challenges of labeling THMs and how the challenges intersect with patient safety. I also hoped that this approach would inform me about critical cases and therefore provide grounds for making “logical generalizations” (Patton, 1990, p. 175) based on the analysis of the data. To be sure, critical case sampling, a type of purposive sampling, involves selecting a limited number of critical cases that have the potential to generate “the most information and have the greatest impact on the development of knowledge” (Patton, 2015, p. 276). On the basis of this approach, I focused on four main factors that allowed me to generate the most important cases:
- Site
- Most commonly sold or used THMs
- Most typical illnesses targeted for potential treatment by the THMs
- Locales where the THMs were commonly sold
My decision on these factors was influenced by my knowledge of the THMs marketplace in Ghana, particularly in the specific terms of the more likely categories of the most commonly used THMs. In addition, I conducted extensive observations of the marketing and purchasing culture of the locale. Ultimately, I focused on Tema, Ghana, which is a major hub for THMs, and a place where traditional herbal clinics and manufacturing companies abound. Then, based on my knowledge of the marketing culture, as influenced by media discussions and my own personal observations, I learned that THMs were typically sold at pharmaceutical shops, stores, public transit systems (e.g., buses), streets, and traditional healthcare centers. All these points of sale were fairly close together, although they were not necessarily in the same neighborhood. However, the marketing locales represented varying types and quantities of THM products and business. I learned that the most commonly sold or used THMs also represented the ailments most commonly treated by the THMs (e.g., malaria, piles, hypertension, menstrual pain, joint pain, body pain, diabetes).
I obtained 15 THM samples for this study by visiting the four typical marketing locations with the goal of purchasing the most commonly used THMs within the locale. Of the 15 THMs, and entirely by chance, six were unlabeled and nine were labeled. I obtained four of the 15 from a popular and registered traditional clinic, two from a bus heading from Tema to Accra, four from a THM store, two from the streets, and three from a pharmaceutical shop that also sold conventional medicine. I did not examine the samples while at each of these purchasing locations. Figure 3 shows a typical label.
The medicines treated the following conditions: malaria, menstrual pain, piles (hemorrhoids), constipation, body pain, rheumatic pain, loss of appetite, genitourinary problems, inflammatory disorders, and fever. Table 1 summarizes the uses of the sampled products and their active ingredients based on the product label. I gathered information about the active ingredients and the indications for the six unlabeled samples from the marketers at the point of sale.
Data Analysis
I analyzed the textual information that accompanied each sample by means of qualitative content analysis, which is a “primary messaging-centered methodology” (Neuendorf, 2002, p. 9). The primary motivation for this approach was to allow themes to emerge from the data. For the purposes of this study, qualitative content analysis was a flexible method for analyzing the primarily textual data and also for “distilling words and other lexical items into fewer concentrated categories” (Cavanaugh, 1997, p. 5). Essentially, each label was a unit of analysis, so I analyzed the textual components of each label individually and noted specific observations, themes, and categories based on the notion of what communication issues were likely to pose the most challenges for patient safety, especially in terms of access and use, and also based on the minimum requirements provided by the Ghanaian FDA.
FINDINGS
The major findings of the analysis include the following based on information generated from the 15 samples selected from the specific locale of Tema (Table 2):
- Of the 15 samples, six samples (10–15; see Table 4) had no labels on the container, neither did they have any inserts in the product boxes.
- Only two of the nine labeled samples included inserts to augment the information provided on the container labels.
- Only two of the nine labeled samples included the statement, “side effects.”
- None of the nine labeled samples included any actual information about potential side effects, incorrectly suggesting that none of the samples included any toxic elements or had the potential to interact with other drugs to cause adverse events.
- All nine labeled samples included information about batch number, Ghanaian FDA registration, manufacturer and distributor address, labels in English, active ingredients, usage indications, storage conditions, and expiration dates.
- Eight of the labeled samples included a precautionary statement such as “not recommended [for] pregnant women, lactating mothers, and children under twelve (12) years.”
- Seven of the nine labeled samples included a statement about children such as “not to be taken/used by children” or “keep out of the reach of children.”
- Seven of the nine labeled samples included information about dosage instructions.
- Only two of the nine labeled samples (samples 6 and 7) met most of the requirements spelled out in the Ghanaian FDA guidelines. In addition to labels on the product container, samples 6 and 7 included inserts that provided details such as a product warning, drug interactions, contraindications, overdose symptoms and treatment, and mode of administration—although both samples stated that the medicines had no side effects.
DISCUSSION
Deficiencies in THM Labeling
The analysis of the samples suggests that as a result of the inadequate or missing technical communication provided by the manufacturers and marketers of THMs, there are serious safety concerns. I found few or no attempts from the manufacturers and the vendors to provide information about pre-existing medical conditions, contraindications, periods of use, who to contact or how to respond in the case of an overdose or complications, detailed dosage instructions, side effects, and potential drug interactions. For example, it appears that many of the labeled samples were simply concerned with superficial features such as batch numbers and registration numbers that are associated with the labels. In some cases, the labels met the barest minimum of the requirements of the Ghanaian FDA. This suggests the priority was to meet the Ghanaian FDA requirements rather than to address the health needs of users. One can argue that from communication and patient safety perspectives, the Ghanaian FDA’s requirements did not go far enough. Nowhere do these requirements emphasize quality of communication; on the contrary, the statement in the Ghanaian FDA guidelines (see Figure 2) that “Labelling shall be informative and accurate” is vague. Is the term “informative” supposed to mean the quality of the English or the level of detail? Thus, one improvement would be to replace the current text with a detailed description of the required content, such as “contains details on contraindications, drug interactions, uses to be avoided.” Essentially, asking for labels to be printed in English only without insisting on the quality of the English or quality of communication is an invitation to manufacturers and marketers to compose documents without considering their effects on users.
The findings also reveal that six of the 15 samples did not include any labels. This is an important omission, since many of the illnesses the THMs treat are chronic and life-threatening conditions that require careful and thoughtful administration of medicine and subsequent management. Of course, in a culture where most instructions about medicinal products are given by word of mouth, it can be assumed that a lot of the instructions associated with THMs are given at the point of sale. My own research in the study locale confirmed this. When I purchased the samples, I received only cursory instructions at the point of sale. Research has, however, pointed out that oral instructions are easily forgotten and misunderstood (Davis et al., 2006). This is a cause for concern because patients may overdose on or wrongly administer medicines.
Another finding is that only two of the nine labeled samples contained a statement about side effects. Even more worrying is the failure of any sample to actually list any side effects. Yet, the active ingredients listed on the medications suggest potential toxic elements which may have biological effects or which may interact with other drugs to produce harmful effects on the human body. For example, sample 3 used in the treatment of malaria lists cryptolepis as an active ingredient; cryptolepis has potential genotoxicity, which could alter the biological functioning of the body. Similarly, phenols, listed as an active ingredient for sample 10, which is used for the treatment of hernias, may have an irritant effect if applied externally instead of internally. These examples illustrate that even when active ingredients may be considered natural, all substances have the potential for misuse and overdose, and are therefore potentially harmful. Of course, there is also a concern about potential interactions with other drugs. In addition, as Nasril and Shirzad (2013) argue, if a drug is effective, it will have side effects, and the fact that none of the samples highlighted this important concept is surprising. Manufacturers cannot trust patients to make the right choices if they fail to provide proper guidance that will assist patient in administering their medicines.
Furthermore, although eight of the nine labeled samples included some material about dosage instructions, information on many of the labels may be confusing. For example, the instructions for sample 3 asks users to take “4 table spoonful, four (4) times daily (160mL).” However, this does not answer the question of how many hours should come between doses, whether the dose should be before or after meals, or frequency. Based on best practices (Davies et al., 2009; Wolf, 2006), a clearer version of this advice would be the following: “At 8 a.m., take 1 tablespoonful (40ml) after eating; at 1 p.m. take another tablespoonful (40ml) after eating; at 6 p.m. take another tablespoonful (40ml) after eating; and at 11 p.m. take another tablespoonful (40ml) after eating. Do not exceed four doses in a day.”
Technical Communicators as Designers of Medicinal Labels
As I argued earlier in this article, creating accessible product documentation is vital for the effective use of every product. To borrow the words of Dwain Simpson (1987), the three most important components to success in information accessibility are “Documentation, Documentation, and Documentation” (p. 34), but ineffective documentation can also render users incapable of using a product. Of course, as designers themselves (Sun, 2006), users may come up with their own creative ways of using a product, but this may come with harmful consequences. Ultimately, documentation should not only be a primary consideration in medicinal product development, but it should also be carefully planned to assist users to navigate the product as easily and as effortlessly as possible so that users can make informed choices about their health. More than three decades ago, Redish (1989) argued that readers of product documentation “read to do” and “read to learn” (p. 289). They “extract information for immediate action” and “absorb information for future recall” (Reddish, 1989, p. 289). The findings from my study show, however, that even the nine labeled samples provided few opportunities for users to safely act on the information they were provided on the labels. The labels should have enabled users to understand the consequences of the choices they were making by purchasing and using the products: how the choices will affect their health and how that compares to the desired outcome. Needless to say, the documentation provided on many of the labels was inadequate and thus appeared likely to be ineffective in meeting the health needs of users; thus, they cannot ensure patient safety.
To be fair, THMs are too complex to be fully described using only a few words on the side of a container, but because failure in communication has the potential to negatively impact the health of patients, as the findings suggest, it is important that manufacturers employ best practices to make medicinal information easily accessible to users. This is particularly true since most THMs have not undergone clinical trials that would reveal side effects and potential drug interactions. Effective container labels, package inserts, and quality oral communication and counseling from trained THM vendors can go a long way toward addressing these gaps. Medicinal plants contain too many different compounds for manufacturers to not document the risk factors associated with the plants and side effects. Vulnerable users, including those with low literacy, elderly patients, and those who live in rural areas, require even more thoughtful attention to the design of labels to communicate effectively. In essence, the use of clear labeling instructions would improve patient understanding. Effective labels facilitate communication with and comprehension by patients, and help them to more accurately access their medications.Admittedly, the problems associated with THM labels may be a function of poor regulatory standards, poor enforcement of these standards, or the misplaced attitudes of manufacturers/marketers towards design, but they are also clearly a problem of poor technical communication and documentation. In Ghana, many manufacturers create THM documentation without using the services of trained communicators, because they do not find the need to do so. Technical communication is not developed as a profession in Ghana so many organizations rely on the services of untrained, in-house personnel or English graduates from universities or journalism schools who are not professional technical communicators to produce their documentation. Some manufacturers believe in the “anyone can write” mantra, and documentation is not seen as a crucial part of product development, as is evident in the study results. Of course, in the rural parts of Ghana, the communication of the use of medicinal products is predominantly by word of mouth, but it is not the case in more urban areas, such as Tema, which have a greater population of educated people.
In any case, because of the health ramifications of poor technical communication in the THM industry in Ghana, it is important that manufacturers and marketers of THMs add trained technical communicators to their teams because of the value technical communicators add to information design and accessibility. Investigating how users interact with information products, and using that understanding to improve the design of those products is a central mandate of technical communication (Lauer & Brumberger, 2016, p. 249). Technical communicators have a long history of collaboration with fields such as engineering, technology, and medicine, and therefore are well-versed in crafting and developing information for these specialized fields that better address the needs of target audiences.
Take, for example, scientists who create new products; they may have the requisite knowledge to define and discuss the methods for using and applying the products, but they may not understand the language the end-user needs to access the products. Being subject matter experts, scientists already speak the language of their products, and therefore may assume that their audiences know what they know. However, with a more intuitive understanding of audiences and rhetoric, technical communicators add value by bridging the gap between the product and the end-user. They conduct research grounded in user analysis to gather the requisite information that will inform information design and accessibility. By their training, technical communicators work closely with subject-matter experts and/or become knowledgeable enough about products to communicate information about the product to users. More importantly for organizations, technical communicators generate “greater return on investment” (Redish, 1995, p. 26) by enhancing user satisfaction and reducing the cost of writing and design without sacrificing quality.
As Slaughter (2009) notes, all organizations share a basic goal: “ensure customer satisfaction at the lowest risk (for the customer and the organization) while earning a profit (or, at least, not losing money)” (p. 13). Certainly, many organizations understand the importance of technical communication, but it is easy for some manufacturers of THMs to see documentation as an unnecessary overhead especially in a context which relies so heavily on oral communication in giving medicine instructions, or which doesn’t hold manufacturers accountable for ineffective or omitted documentation. Technical communicators must, therefore, make the “value-added” case to the manufacturers of THMs.
In her seminal article, “Adding Value as a Professional Technical Communicator,” Redish (1995) explores the value of technical communicators in organizational contexts by highlighting how technical communicators “improve productivity” (p. 26), “increase benefits” (p. 27), and “reduce costs” (p. 27). Specific to the issue of cost, she argues that technical communicators add value in a number of ways: (i) reduce the cost of documentation without sacrificing quality, (ii) produce high-quality documentation by reducing post-market expenses and usability issues, and (iii) contribute to the overall improvement in an organization’s return on investment (p. 30-31). In many ways, technical communicators take on a diversity of roles that extend beyond writing and design. They understand the value of audience-specific documentation while also justifying its value in economic terms.
Slaughter (2009) also identifies some of the more tangible ways technical communicators add value: (i) user advocacy through documentation design and usability testing, (ii) improved documentation for product support, (iii) support for marketing and sales, and (iv) affordability and quality (p. 13). Essentially, getting design and writing right could be less costly than a lack of or inefficient documentation design. Hiring a technical communicator to write product documentation could provide a number of benefits for both users and THM manufacturers. For example, technical communicators could help manufacturers avoid needless lawsuits, harm to users, and waste of time and resources while demonstrating the effect of poor design on product usability and on users’ lives as well as the overall impact on an organization’s reputation. These issues are all areas of expertise that technical communicators can bring to the context of a cost-benefit analysis.
Certainly, technical communicators offer both economic and non-economic benefits to organizations. They organize, simplify language, design, and convey complex processes in a patient-centered manner. They thoughtfully negotiate the flow of information from the viewpoint of the user (Slack, 2003), and they are the first and last lines of advocacy for the users. These are all important for the THM sector. Technical communicators are not just writers but content experts in information creation, management, and strategic thinking. They add value to product documentation by serving as important quality assurance product testers “whose role is to . . . work with the developers to eliminate flaws and bugs” (Mead, 1998, p. 362). As a result of their training and work with product development and subject matter experts, technical communicators “are a repository of knowledge in a company” (Mead, 1998, p. 363) and, therefore, “hold a position of communication power” (Smudde, 1993, p. 36). Essentially, they are at the front line of patient advocacy and safety, because they are the professionals to deliver the most accessible and tangible design and communication to users. Ultimately, the risks involved in leaving the labeling of THMs in the hands of untrained technical communicators may be far too great and too costly for users and manufacturers. Rather, both users and manufacturers will have better value for their investment in the THM products if technical communicators design the THM documentation. We thus need to focus on our role as content experts, not just as writers.
This study points to the inadequacy of clearly written information for THM products in Ghana. It also establishes that issues surrounding non-conventional pharmaceutical practices intersect with technical communication in the areas of information accessibility, health communication, information design, and document design, but manufacturers and vendors should not be trusted with the lives of users.
CONCLUSION
Although medical and health communication is a growing area in the field of technical communication, the specific area of patient safety remains underexplored. Moreover, the relationship between patient safety and THMs is an important aspect of the healthcare needs for many people, particularly those in the developing world. It therefore deserves more attention in the field of technical communication. Effective labeling and documentation practices are access and safety issues, because the availability of well-designed health information in the form of labels and package inserts are essential for users to make informed decisions about their health. This is particularly true in the Ghanaian context, in which many users of THMs obtain these medicines without consulting a medical professional. It will be important for future research to highlight the experiences of users in their use of THMs in relation to the quality of the information they receive.
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ABOUT THE AUTHOR
Godwin Agboka is associate professor of technical and professional communication (TPC) at the University of Houston-Downtown, where he teaches graduate and undergraduate courses in TPC. His research interests include intercultural communication, social justice, human rights, medical and science communication, legal writing, and research methodologies as they relate to cross-cultural contexts. His publications have appeared in Technical Communication Quarterly, Technical Communication, Journal of Business and Technical Communication, Journal of Technical Writing and Communication, and Connexions: International Professional Communication Journal. He has also co-edited special issues and book collections.