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International Journal of Physical Distribution & Logistics Management

Enhancing supply chain visibility in a pharmaceutical supply chain - solutions based on automatic
identification technology
Marcel Papert Patrick Rimpler Alexander Pflaum
Article information:
To cite this document:
Marcel Papert Patrick Rimpler Alexander Pflaum , (2016),"Enhancing supply chain visibility in a pharmaceutical supply
chain - solutions based on automatic identification technology ", International Journal of Physical Distribution & Logistics
Management, Vol. 46 Iss 9 pp. -
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http://dx.doi.org/10.1108/IJPDLM-06-2016-0151
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Enhancing Supply Chain Visibility
in a Pharmaceutical Supply Chain
Solutions based on automatic identification technology
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ABSTRACT
Purpose
This work analyzes a pharmaceutical supply chain in terms of supply chain visibility
(SCV). The current Good Distribution Practice (GDP) guideline demands increased
visibility from firms. The purpose of this study is to propose a solution for SCV
enhancements based on automatic identification (Auto-ID) technologies.
Design/methodology/approach
We qualitatively analyze data from 10 case studies of actors in a pharmaceutical supply
chain. A review of Auto-ID technologies supports the derivation of solutions to enhance
SCV.
Findings
This work shows that the functionalities of Auto-ID technologies offered by current
practical monitoring solutions and challenges created by the GDP guideline necessitate
further SCV enhancements. To enhance SCV, we propose three solutions: securPharm
with passive radio frequency identification (RFID) tags; transport containers with sensor
nodes; and an SCV dashboard.
Research limitations/implications
This study is limited to a pharmaceutical supply chain in Germany and is therefore not
intended to be exhaustive. Thus, the results serve as a foundation for further analyses.
Practical implications
This study provides an overview of the functionality of Auto-ID technologies. In
juxtaposition with the influence of the GDP guideline, the use of our Auto-ID-based
solutions can help to enhance SCV.
Originality/value
This work analyzes a pharmaceutical supply chain in Germany, with consideration given to
the influence of current legislation. Based on a multiple-case-study design, we derive three
Auto-ID-based solutions for enhancing SCV.
Keywords Supply chain visibility, pharmaceutical supply chain, automatic identification,
RFID, sensor, Internet of Things, case study, Good Distribution Practice
Paper type Research paper
Introduction
In the high-selling pharma market (Institute of Healthcare Informatics, 2012), a combination
of product counterfeiting, errors in the production and distribution of temperature-sensitive
drugs, the theft of expensive products, and faulty drugs resulting from incorrect ingredients
lead to multi-billion-dollar revenue losses throughout the world and constitute a serious threat
to public health. Against this background, various guidelines support the actors of
pharmaceutical supply chains (PSCs) to ensure correct drug handling (EU, 2013; WHO,
2014). The latest European Union guideline for the Good Distribution Practice (GDP) of
Medical Products for Human Use has been effective since September 2013 and challenges the
actors to ensure and prove correct drug handling throughout the entire PSC (Spiggelkötter,
2013). Consequently, actors in PSCs are forced to enhance supply chain visibility (SCV).
SCV can be defined as “the extent to which actors within a supply chain have access to or
share information which they consider as key or useful to their operations and which they
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consider will be of mutual benefit” (Barratt and Oke, 2007, p. 1218). Such visibility helps
actors to achieve an enhanced overview of material flows within complex supply chains
(Christopher and Lee, 2004; Christopher and Towill, 2001). As Barratt and Oke (2007)
mentioned, SCV results from information being shared between supply chain actors (see also
Christopher and Lee, 2004) and can have a positive effect on supply chain management
(Delen et al., 2007; Jonsson and Mattsson, 2013; Lumsden and Mirzabeiki, 2008). However,
SCV and information sharing require the adoption of monitoring solutions based on automatic
identification (Auto-ID) technologies (Angeles, 2005; Kärkkäinen and Holmström, 2002; Lee
and Özer, 2007), which enable information gathering, sharing (Attaran, 2007; Spekman and
Sweeney, 2006) and an overview of material flows (Holmström et al., 2010; McFarlane and
Sheffi, 2003).
Against this background, we argue that the functional capabilities of current technologies
for practical monitoring solutions, such as barcodes, data matrix codes and data loggers, are
insufficient to enhance the pharmaceutical SCV and to ensure and prove that drug handling
satisfies the GDP guideline. To support this assertion, we cite other studies on Auto-ID
technologies with advanced functional capabilities that are promising in relation to enhancing
SCV (Prockl and Pflaum, 2012; Sanchez Lopez et al., 2011; Zheng and Jamalipour, 2009).
However, to provide Auto-ID-based solutions for enhancing SCV, it is necessary to conduct a
detailed examination of the functional requirements of PSC process activities under the
influence of the GDP guideline, and of the functional capabilities of Auto-ID technologies.
This study aims to provide such an examination, leading to the following research question:
RQ. How can SCV be enhanced using Auto-ID technologies within a PSC?

To answer this research question, we begin by reviewing the SCV literature and its
relationship with Auto-ID technology. Next, we present the design of the empirical research
scheme based on 10 case studies, from which we derive Auto-ID-based solutions for
enhancing SCV. To derive the solutions, this study takes a supply chain perspective by
considering the actors and their physical process activities (see Hinkka et al., 2012; Hinkka et
al., 2015; Spekman and Sweeney, 2006). This perspective is used because we will only obtain
real enhancements in SCV by considering a supply chain perspective (Christopher, 2011;
Spekman et al., 1998). Our solutions provide both insights into the implementation of drug-
centric monitoring with accurate and secure information handling for SCV, and information
that will help to prove that drug handling satisfies the GDP guideline. Finally, this paper
emphasizes the importance of Auto-ID technologies for information gathering and sharing in
supply chains (Christopher and Holweg, 2011), and is, to the best of our knowledge, the first
study that analyzes the influence of the current GDP guideline (legislation) on SCV in a PSC
context.

Review of supply chain visibility and Auto-ID technology


This section reviews the research on SCV and Auto-ID-based monitoring solutions. The goal
is to clarify the essence of SCV and its relationship with Auto-ID technologies. Following
Denyer and Tranfield (2009), a keyword search was conducted in the journal databases
EBSCO and ScienceDirect to harvest the maximum possible relevant research published to
date. Supply chain visibility, automatic identification and intelligent products were used as
keywords because SCV is central to our study and is realized by products equipped with
Auto-ID technology (i.e., intelligent products). Moreover, we also availed ourselves of the
references within these first-tier articles to exploit further relevant publications. Publications
not sufficiently related to our focus were excluded based on their title, abstract, and, if
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necessary, the full publication.

Supply chain visibility


Various definitions of SCV are available within academia. Kaipia and Hartiala (2006, p. 377)
define SCV as “... the sharing of all relevant information between supply chain partners, also
over echelons in the chain,” which emphasizes that SCV only results from the sharing of
meaningful information between all relevant supply chain actors. Barratt and Oke (2007)
define SCV as the extent to which supply chain actors have access to useful and mutually
beneficial information. Thus, SCV emerges from shared information, which offers value and
advantages for supply chain management. This information leads to visibility, which in turn
improves operational activities, such as inventory management, operational effectiveness, and
efficiency. A further definition of SCV is given by Francis (2008), who emphasizes the types
of information involved in the entities moving along the supply chain, and the timely delivery
of event information. The types of information include identity, location, and status quo.
Thus, this definition details which information should be shared in order to achieve SCV.
Whereas these definitions focus on the value of information sharing between supply chain
actors and the types of information shared, Klueber and O’Keefe (2013) introduce the concept
of requisite SCV. They define requisite SCV as the provision of information from different
supply chain stakeholders and access to this information for mutual business benefit.
Furthermore, this concept stresses the need to assess visibility in a supply chain and to
identify aspects that influence SCV. With this definition, Klueber and O’Keefe (2013) extend
the perspective of information sharing from supply chain actors to supply chain stakeholders
and thereby the scope of such sharing. However, the authors found no single, consistent
definition of SCV within the literature (see also Caridi et al., 2014). Table I shows the
aforementioned definitions.

Please insert “Table I. Definitions of SCV.” here.

With regard to our research purpose and methodology, it is necessary to provide a conceptual
framework for SCV to support our work. Therefore, the authors synthesized the
aforementioned definitions of SCV to devise dimensions that operationalize SCV and
represent cornerstones of a conceptual framework. Basically, the authors follow the definition
of Barratt and Oke (2007) and thus consider the aspect that object information should be
permanently available to all supply chain actors (which is beneficial to the entire supply chain
and can, for example, help to achieve proof of GDP-consistent drug handling). As this aspect
is also represented in the definitions of Kaipia and Hartiala (2006) and Klueber and O’Keefe
(2013), the authors derived availability of information as one dimension of a conceptual
framework. As mentioned above, this study aims to enhance SCV, which should help to
provide proof of GDP-consistent drug handling. Therefore, a conceptual framework for SCV
must also consider relevant types of information. In this sense, the authors incorporated the
definition given by Francis (2008) and added the aspects of identity, position, and status quo
as further dimensions for SCV. The authors did not give further consideration to the requisite
supply chain visibility (RSCV) concept given by Klueber and O’Keefe (2013) because it is
generic, strategic, and qualitative in nature. It therefore does not support the derivation of
detailed supply chain related solutions to enhance SCV, especially from a supply chain
perspective. Table II shows our dimensions of SCV, with explanations.

Please insert “Table II. Conceptual framework with SCV dimensions and explanation.” here.

Furthermore, the aforementioned insights into SCV definitions emphasize that information
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sharing is an important prerequisite for SCV (see also Barratt and Oliveira, 2001; Bartlett et
al., 2007; Christopher and Lee, 2004; Holcomb et al., 2011; Lamming et al., 2001; Steinfield
et al., 2011). Such information sharing, in turn, requires the use of monitoring solutions with
suitable Auto-ID technology (Kärkkäinen and Holmström, 2002) and related information
technology (IT) systems to monitor material flows (Hinkka et al., 2015; Hinkka et al. 2012)
and to share valuable information among supply chain actors (Attaran, 2007; Delen et al.,
2007; Holmström et al., 2010; Lee and Özer, 2007). Therefore, SCV may be seen as resulting
from information gathering and sharing and from applying an appropriate Auto-ID
technology. Moreover, to be of value, information must relate to a certain purpose in supply
chain management.

Auto-ID technologies and their functions as an enabler for SCV


Auto-ID technologies were originally developed to create a global network of physical objects
with a digital identity in information systems (Internet of Things). This should provide
detailed information about the flow of materials and improve supply chain processes
(McFarlane and Sheffi, 2003). To vertically integrate information and material flows, physical
objects are equipped with Auto-ID technologies. Examples of such objects are intelligent
containers, which can record temperature and communicate their position (Lang et al., 2011).
Auto-ID technologies are defined as technologies that enable automated, accurate, and
detailed identification of objects (Kärkkäinen and Holmström, 2002; McFarlane and Sheffi,
2003), with the possibility of additional acquisition of information for enhanced data quality
and vertical integration between information systems and material flows (Holmström et al.,
2010; Meyer et al., 2009). In this sense, such technologies help to improve efficient material
handling and customization (Kärkkäinen and Holmström, 2002). Auto-ID technologies
include radio frequency identification (RFID), RFID with integrated sensors and wireless
sensor networks with sensor nodes (WSNs), and focus on automatic identification and data
acquisition (Meyer et al., 2009; Miles, 2008). Sensor nodes are small computer tags that can
communicate with one another and build a sensor network with redundant communication
paths (Zheng and Jamalipour, 2009). However, based on their technological characteristics,
these technologies may contain the following functions (Lempert and Pflaum, 2011; Prockl
and Pflaum, 2012):
(1) identification (unique identification of object);
(2) locating (accurate information on object position);
(3) sensors (current status of object);
(4) communication (accessibility of object);
(5) data storage (retention of object history);
(6) logic (recognition of critical events of object).

Regarding our SCV dimensions and the aforementioned functions, Auto-ID technology is
theoretically capable of realizing the dimensions. As our SCV dimension of availability
demands information sharing between supply chain actors, Auto-ID technology with a
communication function can provide object information for exchange. Additionally,
availability can be supported by a data storage function that considers storage volume for
object information. Without such storage volume, information can be neither stored nor
shared. Moreover, an identification function can support the dimension of identity by
providing identity information about an object. Similarly, a locating function can support the
dimension of position by providing accurate information about the object’s position.
Considering the possibility of a sensors function, the dimension of status quo would be
supported because sensors can provide object- or environmental-related information. By
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recognizing critical events of an object, a logic function can further provide useful
information about the dimension status quo. For example, if a logic function is able to
recognize a temperature transgression of a temperature-sensitive object, then the status of the
object’s quality can be indicated accordingly. Consequently, functions of Auto-ID technology
help to realize our SCV dimensions and therewith to create SCV.
Furthermore, the presented Auto-ID functions can be specified with quantitative degrees of
performance (assessed on a scale from 0.25 to 1; Prockl and Pflaum, 2012). Table III shows

Please insert “Table III. SCV dimensions and related Auto-ID functions with degrees of
performance.” here.

the SCV dimensions, the related Auto-ID functions, and degrees of performance. In this
sense, these degrees can be used to operationalize Auto-ID functions and the realization of
SCV dimensions. In other words, if an Auto-ID technology allows the provision of object
identity at product level by identification, then the degree of performance for the
identification function of this Auto-ID technology is unity. Consequently, the SCV dimension
of identity would be completely realized. If a function of an Auto-ID technology does not
satisfy any related degrees of performance, then the degree of performance of this function is
zero. Consequently, the related SCV dimension is not realized. Moreover, if the degree of
performance of each function of an Auto-ID technology is unity, then the given technology
allows the realization of all SCV dimensions as far as possible, and thereby full SCV in terms
of our conceptualization. Finally, a net diagram can visualize the degrees of performance for
each function of an Auto-ID technology. The resulting net area then shows how the related
SCV dimensions are realized. As Auto-ID technologies and their functions enable SCV, the
following sections provide an overview of Auto-ID-based monitoring solutions. This
overview results in a functional evaluation of the introduced Auto-ID technologies and a
presentation of the theoretical deficiencies and benefits of Auto-ID technologies for realizing
the SCV dimensions.

Overview of Auto-ID-based monitoring solutions for SCV


The characteristics of Auto-ID technologies have led to the development of manifold
solutions for monitoring supply chains, in which RFID-based solutions are predominant
(Hinkka et al., 2015). Kärkkäinen et al. (2003) proposed a system to monitor and control
products in investment projects. By endowing products with RFID tags, these products obtain
a unique identity and can communicate their information to tracking services (availability). A
peer-to-peer information system with distributed software techniques supports the exchange
of information between supply chain actors. Kärkkäinen et al. (2004) present a forwarder-
independent approach to monitoring objects in short-term supply networks to overcome the
difficulties associated with manual information queries and system integration. This solution
is similar to that of Kärkkäinen et al. (2003) but applies distributed software components and
peer-to-peer information sharing (availability). For the grocery supply chain, Martínez-Sala et
al. (2009) propose using intelligent returnable packaging and transport units in combination
with an information system to track transport units. While the transport unit is equipped with
an RFID tag, the system gathers all the information on the units using RFID technology
(identity). This solution enables transport-unit or package-level monitoring and traceability,
and the possibility to save additional information at transport-unit level (availability). For the
book supply chain, Hinkka et al. (2012) offer recommendations for retailers about where and
when to tag books with RFID technology for implementation throughout the supply chain.
Their study shows that speculative book tagging as early as possible throughout the entire
chain increases supply chain agility by improved sharing of detailed information at object
level (availability, identity). Mason et al. (2012) propose an inventory management system
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based on RFID technology to monitor returnable gas cylinders. Gas cylinders are equipped
with an RFID sensor tag capable of peer-to-peer communication (availability) to transmit not
only information about the cylinder (identity) and status quo but also a logical mapping
information (position) to an RFID reader. Inventory software manages all the information
collected and facilitates cylinder monitoring. Hafliðason et al. (2012) present a study on how
WSNs can support temperature monitoring in food supply chains to assist decision-support
systems. To record both food and ambient temperature, sensors are added to the shipments
(status quo). This recorded information enables the identification of failures at shipments
within the food supply chain (identity, position), temperature alerts, and the real-time
monitoring of shipped products (availability).

Overview of current practical monitoring solutions for SCV


In PSCs, data loggers are used for temperature monitoring (DHL, 2015). Data loggers are
small objects that measure temperature and store temperature profiles (status quo). An
integrated sensor captures temperature data at predefined intervals and saves this data in the
data logger’s memory (availability). The data loggers are then put into the transportation
accessories of the drugs to monitor temperature profiles. A data logger records a temperature
profile but does not protect the drugs against excessively high or low temperatures. In other
words, a logic or regulating function for temperature control is missing.
To monitor deliveries along entire PSCs, barcodes are used to identify and control drugs
(Hansen and Gillert, 2008). However, in view of its limited information density, the barcode
cannot prevent counterfeit products from entering the supply chain. As a result of the
simplicity and benefits of the data matrix code (securPharm, 2014), the pharmaceutical
industry demands its use, which allows for identification at product level (identity) and
therefore provides greater visibility. A solution associated with the data matrix code is
securPharm, which is defined as a drug verification system whereby unique identifiers are
stored in a repository and are accessible (availability) by national competent authorities
(securPharm, 2014). The development of this system is being expedited by the EU, which
demands a secure system against product counterfeiting for all EU member states as of 2017.
Medicine labelling consists of applying a data matrix code (standardized ISO coding,
ISO/IEC 16022) to ensure global and unique readability. The code consists of a product
number, charge number, expiration date, and unique serial number. To allow the verification
process, the data matrix code is printed on the product packaging. In parallel, the code is
stored in a central database (A) of all participating product manufacturers. Furthermore, the
code is copied onto a second database (B) that only pharmacies and wholesalers can access.
Additionally, the system entails separate storage and anonymized retrieval sections, which
facilitate the protection of sensitive business information and personal data. This separation
also ensures that no stakeholder can access the data of other stakeholders. For example,
pharmacies can verify the authenticity of product packaging by scanning the product.
Thereafter, the information from the code is compared with information from database (B).
For an original medical product, scan information and database (B) information are
equivalent.

Functionality profiles of reviewed Auto-ID technologies for realizing the SCV dimensions
Table IV presents an overview of the functionalities of the Auto-ID technologies evaluated by
using the degrees of performance of functions given in Table III. The preceding literature
review provided the information for this overview. In addition, Auto-ID-technology
information from Finkenzeller (2010), Prockl and Pflaum (2012), Lempert and Pflaum
(2011), and Zheng and Jamalipour (2009) supported this evaluation. We thus evaluated the
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degree of performance of each Auto-ID function shown in Table III for each Auto-ID
technology presented in the preceding overview.

Deficiencies to realize the SCV dimensions


The net diagrams in Table IV show the reviewed Auto-ID technologies with their functions
and degrees of performance. These net diagrams demonstrate that, in particular, the current
practical monitoring solutions exhibit functional deficiencies to realize the SCV dimensions.
Specifically, the data matrix code of securPharm and the barcode do not support a sensors and
logic function. These missing functions therefore prevent the realization of the SCV
dimension of status quo. In addition, barcode and data matrix code do not offer rewritable
data storage, which impedes the availability dimension, as no further information can be
added for information sharing, especially at object level. The data logger, in turn, does not
offer an identification function, which impedes the realization of the identity dimension.
Additionally, the missing logic function of a data logger negatively influences the realization
of the status quo dimension, as no events of objects can be recognized. Consequently, the
review shows that the functions of Auto-ID technologies from the current practical
monitoring solutions are not sufficient to realize all dimensions of SCV.
A detailed consideration of the net diagrams of RFID, RFID with sensor, and WSNs shows
that the identification, locating, communication, and data-storage functions are at least as
powerful as the analogous functions of a data logger, a barcode, or a data matrix code.
Although RFID technology lacks a logic and sensors function, which prevents it from
realizing the SCV dimension of status quo, these Auto-ID technologies are theoretically better
suited to the realization of the SCV dimensions. Moreover, RFID with sensor differentiates
itself from data logger, barcode, or data matrix code by virtue of its identification and sensor
functions. As RFID with sensor lacks only a logic function, realization of the SCV dimension
of status quo would only be diminished by the missing recognition of critical object events.
Moreover, WSNs are basically capable of all required Auto-ID functions and thereby allow
the realization of all SCV dimensions.
In this context, the authors emphasize that Auto-ID technologies from the current practical
monitoring solutions exhibit clear deficiencies that prevent them from realizing all SCV
dimensions. Therefore, we argue for an examination of the PSC under consideration of, in
particular, the Auto-ID technologies RFID, RFID with sensor, and WSN to enhance SCV.
However, as these technologies do not completely enable all six Auto-ID functions (not all
functions have a unity degree of performance), such an examination must include a detailed
analysis of PSC process activities, SCV challenges, and their requirements on the SCV
dimensions to derive a feasible Auto-ID-based solution.
Please insert “Table IV. Functionality profiles of Auto-ID technologies from reviewed
monitoring solutions.” here.

Design of empirical research and methodology


Design of empirical research
In our study, we elaborate the requirements on our SCV dimensions and a feasible Auto-ID-
based solution through detailed analysis of a PSC. Thus, we chose a case-study research
design (Eisenhardt, 1989; Yin, 2014) because it allows for the gathering of detailed
information (Aastrup and Halldórsson, 2008; Harding, 2013; see e.g. Hammervoll et al.,
2014), and serves our exploratory objective. Particularly because the PSC network is complex
(Rossetti et al., 2011) and because very little knowledge exists regarding how to enhance
SCV in this network, we considered a qualitative research approach to be appropriate. To
ensure the quality of our case-study research, we focused on the criteria recommended by da
Mota Pedrosa et al. (2012).
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The first important aspect of conducting case-study research is the design of the study
(Yin, 2014). In line with our research objective, the PSC network forms the coherent context
of this study. Figure 1 shows the actors within the PSC network in Germany, with
transportation service providers (TSPs) represented by black arrows (Abramovici et al.,
2010). The difference between a TSP and a logistics service provider (LSP) here is that an
LSP realizes value-added services, such as the labelling or creation of drug-promotion
packages. A TSP is only responsible for drug transportation without realizing any value-
added services. As a result of the complexity of the PSC network, the study focuses only on
the dashed line in Figure 1, which represents the most common chain in drug supply.
Accordingly, this focus constitutes our research premise. We chose an embedded multiple-
case study, in which the actors along this PSC represent the various cases. As the cases
represent the actors, our design enables a detailed end-to-end analysis of process activities and
drug flow along our focused PSC. By this design, we are able to completely describe the most
common chain of drug supply and identify process related requirements on SCV.
Next, we acquired different companies from the pharmaceutical sector that match our
focus in Figure 1. Table V gives an overview of the case companies. According to Yin (2014),
the sampling of a multiple-case design follows replication logic that also supports external
validity. To assure external validity, we selected at least one case company for each actor in
our focused PSC. To simplify the study, we did not include a packaging service provider.
However, this does not affect the results of our study because the packaging service is
integrated into the upstream value-creation stage (pharmaceutical manufacturer).

Please insert “Figure 1. Actors within the PSC network (Abramovici et al., 2010).” here.

We began our study with a drug producer and acquired two other drug producers with
packaging activities to replicate insights into process activities and SCV challenges.
Similarly, we acquired different LSPs and a TSP to obtain insights into process activities and
SCV challenges. In so doing, we also tried to acquire firms of varying sizes and revenues to
increase the external validity of our analysis (Yin, 2014). Next, we included two pharmacy
cases to gather replicated insights into this stage of the focused PSC. Finally, we included one
wholesaler company to analyze the related process and SCV challenges. The study includes
only one wholesale partner because only a few wholesalers are active in the German market.
This wholesaler is active throughout Germany and a member of a nationwide union of
pharmaceutical wholesalers, making it a representative case company for this stage in the
supply chain.
Please insert “Table V. Overview of case companies.” here.

Data collection
The case studies were conducted between the winter of 2013 and the spring of 2014. During
the studies, data collection involved expert interviews, firm visits, discussions, and
documents. These multiple sources support data triangulation and construct validity (Yin,
2014). The goal was to understand the viewpoint of the companies (key informants) regarding
process activities and SCV challenges. We conducted one management-level expert interview
with each case company, with ten expert interviews in total. Table V shows the position of the
experts involved in the interviews. Furthermore, each case company was visited to understand
and analyze process activities for drug handling, information gathering and sharing, and the
challenges of SCV. In so doing, we obtained 10 more interviews with employees of the case
companies who were responsible for the processes on a physical supply chain level. These
interviews involved further process discussions.
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We applied a structured interview guideline (see appendix) to allow a complete and


comparable information inquiry and to ensure research reliability (Yin, 2014). We developed
the guideline following Bryman and Bell (2011). Based on our central research question and
our conceptual framework, we derived an initial structure with topics and open questions.
This guideline was pre-tested in terms of comprehensiveness, complexity, and interview
duration. After revision, the interview guideline comprised four topics, beginning with an
explanation of our research purpose. After gathering facesheet information, the third topic
focused on processes and SCV. The experts were asked to describe their process activities and
SCV challenges, their current use of Auto-ID technologies, information sharing, and the
requirements needed to enhance SCV. The interview guideline finished with the possibility
for interviewees to make further remarks. All 20 interviews were audio-recorded and
transcripts were created to support data analysis.
Moreover, we considered the notes of our accompanying discussions in the analysis. The
study partners were allowed to check our transcripts, notes, and interpretations to ensure their
veracity. In addition, firm visits allowed us to observe the processes in real time.
Nevertheless, interviews can be biased and reflexive (Yin, 2014); it is difficult to achieve
broad coverage of all processes during firm visits, and related activities might proceed
differently (Yin, 2014). For these reasons, the case companies provided documentation on the
process activities and the pharmaceutical sector to support the study. Although such
documents provide specific insights and are unobtrusive, they also exhibit the weaknesses of
selectivity and reporting bias (Yin, 2014).

Data analysis
Data analysis basically consisted of a time-series analysis, which implies the examination of
how events influence activities and allows the development of theoretical solutions (Yin,
2014). In this sense, we examined the process activities [1] and determined the challenges that
are needed to overcome to enhance SCV and enable proof of adherence to the GDP guideline
for drug handling. Based on this examination, we identified requirements for our SCV
dimensions to overcome the challenges. We subsequently discussed these requirements with
the reviewed Auto-ID technologies to determine which Auto-ID technology is capable of
meeting the requirements of overcoming the challenges, respectively. We then derived
solutions of Auto-ID technologies from the findings of the analysis and from the insights
provided by the case companies. Our derivation was further supported by discussions with the
case companies and by comparisons with published studies to ensure construct- and internal-
validity and to provide feasible solutions for our focused PSC. At the end of the study, we
presented the final solutions to our case companies. The next section describes the process
activities in our studied PSC. This description is based on our empirical research and should
facilitate an understanding of the process activities, challenges, and the identification of
requirements on SCV dimensions.

Case description and identification of requirements for SCV


Against the background of past pharmaceutical drug disasters (e.g. Lipobay in 2001), and
because of the importance of drugs to public health, controlling institutions such as the
European Medicines Agency (EMA) in Europe and the Food and Drug Administration (FDA)
in the USA were established and now issue strict regulations. The FDA is concerned with the
safety of human and veterinary drugs to protect public health, especially in the USA (FDA,
2015). This agency also provides consumers with detailed and scientific information on
medicines. For pharmaceuticals, both prescription and non-prescription drugs fall under the
FDA’s regulatory jurisdiction. The European counterpart of the FDA is the EMA, which is
responsible for the scientific evaluation of new medicines and the delegation of marketing
authority in Europe (EMA, 2015). Moreover, to protect public health, the EMA’s
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responsibility includes monitoring the safety status of medicines. Through the new GDP
guideline, actors in the PSCs are even more obliged to prove correct drug handling
(Spiggelkötter, 2013).
At the pharmaceutical manufacturing stage, outgoing consignments demand a temperature
check, currently conducted using an infrared thermometer. As the GDP guideline stipulates
reliable temperature surveillance, the interviews revealed that, because of reflective materials
in drug packages and different temperatures both within and outside pallets, automated
temperature recording and temperature checks are a challenge to increasing check reliability.
Thus, temperature sensing and a record of temperature data were identified as requirements.
The temperature record should also allow the temperature profile to be created upon delivery,
as requested by the GDP guideline. Furthermore, the process of loading incoming trucks is
not reliable. For customized consignments, incorrect loading sequences resulting from
precarious identification by barcodes lead to incorrect deliveries, which subsequently reduce
the lifetime of the drugs. At this point, approximately forty to fifty trucks must be loaded (full
truckload) per day. Consequently, this process constitutes a challenge to the implementation
of accurate drug identification. Therefore, to avoid loading failures, the authors identified the
requirement of an accurate identification of drugs.
In the following stage, which falls under the responsibility of the TSP, the consignments
must pass various scan points. In the event of cross-docking, the consignments must pass
approximately twenty scan points. Otherwise, they must pass approximately forty scan points
due to interim storage. Despite the use of barcodes, consignments are not guaranteed to reach
the correct transport vehicle for further transport, even if they have been scanned. Human
errors and scan activities before the loading process hinder these activities. Therefore, the
challenge lies in accurately scanning the drugs throughout this process. Such scanning
activities and the communicated drug identity would support employees in correctly assigning
the consignments to the transport vehicles. To further increase the reliability of assignments,
the authors recognized a demand for assignment verification. Consequently, we identified the
requirements of an accurate identification of drugs and a kind of logic that enables automated
assignment verification (i.e., to ensure that the drugs are consigned to the correct vehicle).
At the stage of LSPs, we identified various processes that represent challenges to
enhancing SCV with the introduction of the GDP guideline. Currently, LSPs manually
measure the temperature of consignments using infrared pistols after truck docking. If the
temperature is acceptable, the drugs are unloaded and scanned. If not, the drug quality is
requested from the pharmaceutical manufacturer. If drug quality is still acceptable, the drugs
are unloaded and scanned; otherwise the consignment is refused. The recognized challenge
here is to provide transport-temperature information in advance, which would accelerate
quality requests and thereby help to maintain the expected distribution rate. Currently,
vehicles are equipped with telematic modules, which transmit information about temperature
and position to the IT system of the LSP. Providing such information in advance therefore
requires a central database in which information is stored and accessible to actors.
A further process activity for LSPs deals with checking the batches (approximately twenty
to thirty pallets) and the size of consignments. The size of consignments differs between, for
example, two pallets of a highly specialized drug and a full truckload of a standard drug.
These checks are currently carried out manually and randomly. Moreover, the following
activities in which drugs are selected and shipped, involve weighing containers to ensure that
orders are complete. This method involves a certain degree of inaccuracy because different
drugs may have similar weights. Of greater concern, however, is the fact that the expiration
date of the drugs (printed on the package) selected is not verified. To increase the rate of
verification while maintaining the expected distribution rate, the case companies must
accurately check the consignment, order completeness, and expiration date. Therefore, we
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identified an accurate identification of drugs in the consignments and containers through a


scanning activity as a necessary requirement. To verify the expiration date, we also
incorporated a kind of logic into the requirements, which would allow reliable verification by
automatically comparing the current date with the expiration date.
Furthermore, LSPs pack individual drug packages together on a pallet in the consolidation
area of the shipping department. In the following process of interim storage, pallets are stored
before being handed over to the transport service provider. In both steps, we recognized the
challenge of correct classification; for example, drug packages may be placed on the wrong
pallet, or pallets may be parked in the wrong temporary storage space. In turn, these
classifications influence the rate of correct deliveries, the distribution rate, and, finally, the
drug’s lifetime. Consequently, the authors identified a logic requirement for verifying
classification (i.e., verifying drugs, pallets, and storage space). Additionally, the process
examination showed that, in the case of misclassification, the challenge is to rapidly find the
right packages or pallets. Such time-consuming searches decelerate the expected distribution
rate. To facilitate such searches in the issuing department, the authors also considered the
provision of spatial position information about missing objects to be a requirement.
At the pharmaceutical wholesaler stage, both the content announcement of combined
incoming consignments and the scan to ensure the order completeness of drugs are performed
manually. The size of consignments encompasses approximately two to three five-tonne
trucks (full truckload). As a result of unreliability, these activities lead to errors in the
subsequent order-selection process of drugs and in consolidation for delivery tours.
Accordingly, the challenge is to ensure accurate content announcements and order-
completeness scans. Therefore, the authors identified accurate identification as a requirement
to support these manual tasks. Moreover, the order-selection process by which drugs are put
into containers requires a further scan process and a final check for order completeness.
According to the study partner, this selection activity should also be optimized, which also
requires accurate identification. Finally, the consolidation of containers to delivery tours
reveals the challenge of correct container classification. Approximately 1500 to 2000
containers must be classified for shipment per day. Due to human errors, this classification
requires an accurate identification of drugs and verification of the container classification
through the comparison of destination information (i.e., comparison between container and
drug destination).
The final process activities include the transport of containers from the pharmaceutical
wholesaler to the pharmacy (final distribution) and the process activities within the pharmacy
itself. These activities revealed only one challenge: automated information logging. Currently,
the wholesaler’s TSP records the delivery of drugs only in exceptional cases, such as
anesthetics. Therefore, no information tracking is possible between the time that the drugs are
handed to the TSP and the end of their arrival at the pharmacy (a black box). This
circumstance also breaks the chain of continuous temperature measurements, preventing the
provision of a temperature profile. In this regard, the case study revealed the requirement for
an accurate identification of the drugs at the onset of transport and an automatic logging of
transport and temperature information at drug level and in a database. Consequently, a record
of temperature information and an information exchange between database and drug level are
required to allow complete information tracking.
Finally, with respect to drug transport, the case companies also mentioned the challenge
posed by theft and counterfeiting. According to the study partners, secure and accurate
identification of the drugs at scan points would facilitate the recognition of stolen and
counterfeit drugs. Consequently, to increase protection against theft and counterfeiting, we
included a requirement for the recognition of unauthorized drug removal with associated date
and position.
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Analysis of requirements for SCV and derivation of Auto-ID-based solutions


This section first presents the relationship between the identified requirements and the SCV
dimensions and an analysis of the necessary functional degrees of performance. In a second
step, these functional degrees are used to derive a feasible solution for SCV enhancements.

Analysis of requirements on the SCV dimensions


Availability. As the dimension availability focuses on sharing and accessibility of
information, we assigned all related requirements to this dimension. Accordingly, the
requirement automatic logging of information at both drug and database level was assigned to
this dimension because drug information should be available at both levels. Such logging,
however, requires a bi-directional communication function of Auto-ID technologies so that
information can be automatically exchanged between drugs and databases at scan points.
Considering Table III, a performance degree of 0.5 was derived for the necessary
communication function. In this context, a helpful Auto-ID technology requires an
appropriate data storage function to allow for information logging at drug level. Based on the
case studies, kilobyte-range data size was deemed sufficient to store temperature and
additional (transport, position) information. Under consideration of Table III, we evaluated
the necessary data storage function with 0.5. Finally, a central database must be considered in
order to store information and provide actors with access to this information.
Identity. This dimension focuses on the provision of identity information. In this sense, we
distinguished accurate and secure identification at drug level as a requirement of this
dimension. Accurate identification logically demands an identification function, specifically,
identification at product level. Giving consideration to Table III, this identification function
has to exhibit a performance degree of 1 for the fulfilment of this requirement. Additionally,
identification at product level must include security. This means that we have to consider a
protection mechanism in the derivation of a feasible solution.
Position. This SCV dimension includes the provision of position information about
objects. In this sense, we assigned the identified requirement provision of spatial position
information to this dimension. To realize the requirement, a locating function is necessary. As
the case study results revealed spatial position accuracy, we selected a required performance
degree of 0.5 for the locating function because this degree corresponds to room-level precise
localization (Table III).
Status quo. This dimension focuses on the provision of information about the status quo of
an object. The information can entail object- and environmental related aspects. Thus, we
assigned all the identified requirements to this dimension that deal with information about
drugs and their environment. In this sense, temperature sensing and a record of this
information were assigned to this dimension. To realize temperature sensing and recording, a
sensors function is essential. As we only want to measure and record one parameter
(temperature), a single sensor for this function is sufficient. According to Table III, the
resulting degree of sensors performance must be 0.25.
Furthermore, we assigned the identified verification and comparison requirements to the
status quo dimension because they deal with drug related information (i.e. verifying drugs, a
comparison of drug and container destination). In this regard, we also dedicated the
requirement recognition of unauthorized drug removal to the status quo dimension because
any information about removal relates to the drug itself. However, the realization of
verification, comparison and recognition demands a logic function. As verification,
comparison and recognition constitute three different events, the logic function must be able
to recognize more than one event resulting in a 0.5 degree of performance (Table III).
Summary of requirements for SCV. To summarize our first analysis, Table VI shows the
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relationships between the identified requirements and the SCV dimensions.

Please insert “Table VI. SCV dimensions and requirements.” here.

Moreover, we illustrated the required degrees of performance for each Auto-ID function in a
net diagram (Figure 2). Accordingly, Figure 2 shows to what extent the functions have to be
met in order to realize the requirements and thereby SCV.

Please insert “Figure 2. Profile of required functionality.” here.

Derivation of Auto-ID-based solutions


By comparing the profile of required functionality (Figure 2) with the functionality profile of
Auto-ID technologies (Table IV), only WSNs are able to meet all the required degrees of
performance without any adverse deviations for the discharge of the requirements. As WSNs
also allow secure identification (Zheng and Jamalipour, 2009), this technology was derived
for the proposition of a first solution to enhance SCV. However, this finding was discussed
with the case companies to ensure the derivation of a feasible solution. Although the selected
WSN technology fulfils all the required functionalities, it involves the implementation of
completely new technology within the focused PSC. In this context, the case companies
indicated the need for a more practical solution, as they are currently working with different
existing practical monitoring solutions (barcode, securPharm with data matrix code, data
logger) and separate IT systems. In this regard, legislation (controlling institutions with
legislative influence and regulatory requirements) and drug (object) characteristics have
already promoted the implementation of current practical monitoring solutions within PSCs.
Thus, the case companies were also open-minded about a solution that is easy to adopt, or one
overall solution, no isolated solution, to enhance SCV. Nevertheless, the capacity to provide
accurate and secure information should be ensured.
Transport containers with sensor nodes. Based on the above discussion, the authors
propose the implementation of WSN technology in the opaque final distribution stage from
pharmaceutical wholesalers to pharmacies (a complete black box). Here, transport containers
are used in closed-loop chains and are properly constructed to be equipped with sensor nodes,
in parallel with the use of a central database. The nodes accompany the containers throughout
this stage, and record and store all required information (Zheng and Jamalipour, 2009). In
addition to providing automated information logging, closed-loop implementation is
economical because the containers are reused (see Mason et al., 2012). However, it is
important to link the containers with a pharmacy order and the corresponding delivery with all
the available information on both the drug and the transport. This allows the unique
assignment of drugs to each individual transport container (identification at drug level).
Verifications are supported because the communication capacity of sensor nodes (Zheng and
Jamalipour, 2009) enables them to trigger an alarm if the transport container is classified to
the wrong delivery. Moreover, the nodes can recognize when transport containers are
removed from a vehicle without authorization (logic; Zheng and Jamalipour, 2009) and can
forward this event, providing both date and position, to the database.
The use of sensor nodes in the stages before final distribution is theoretically possible but
requires the equipment of each pallet used with a node. However, equipment with sensor
nodes is not economical as a result of the use of pallets in open-loops. Additionally, if a pallet
is equipped with a sensor node then temperature is only measured at the bottom of this pallet.
During our process observations, we also validated the fact that equipment of each drug
package with a sensor node is neither feasible nor economical. Against this background, we
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propose the use of sensor nodes in the black box final distribution, in addition to the use of
existing monitoring solutions in the upstream stages of the PSC.
However, as the case companies prefer a solution that synthesizes current practical
monitoring solutions that have already been implemented, we derived further solutions to
improve SCV. Nevertheless, we gave consideration to accurate and secure identification and
Figure 2.
securPharm with RFID tags. As a result of the benefits of securPharm (2014) and its
database, the authors included this approach to provide a further, synthesized and more
refined solution. A comparison of Figure 2 with our Auto-ID review shows that RFID is only
lacking in a sensors and logic function. This means that the use of RFID would only impede
the realization of the SCV dimension status quo. However, the comparison also shows that
RFID with sensor exhibits inadequate degrees of performance in terms of locating,
communication, and logic function impairing the SCV dimensions position, status quo, and
availability. Based on this comparison, we propose the use of rewritable RFID tags
(Finkenzeller, 2010) inside drug packaging in combination with securPharm. Regarding its
functionality profile in Table IV, RFID can fulfil the required functionalities of identification,
locating, communication, and data storage. Accordingly, the requirements 1.1, 1.3, 2.1 and
3.1 from Table VI can be met. In this context, further information on temperature and
transport would be stored at drug level along the PSC but would require manual scanning.
Therefore, only manual information logging is possible (Req. 1.2). Unfortunately, as the
required sensors and logic functionalities cannot be realized by RFID tags, requirements 4.1,
4.2, and 4.3 from Table VI cannot be met. Consequently, related activities, such as
temperature recording with infrared pistols, must be carried out manually using existing
techniques or they will require further improvements. However, as information is also stored
on the central securPharm database, the provision of temperature data in advance is ensured.
Nevertheless, RFID can be read out or manipulated (Finkenzeller, 2010), whereby secure
identification requires a further protection mechanism. The authors thus propose secure
identification by the redundant storage of drug information in the central securPharm database
and on RFID tags. Accordingly, counterfeit drugs may be identified if the tag and database
information are not identical. However, despite its implementation in open-loop chains, this
solution does not realize automatic information logging.
Finally, our solution relating to securPharm with RFID is similar to the reviewed
monitoring solution of Kärkkäinen et al. (2003); however, it synthesizes that work by
including the securPharm solution. In other words, drugs carry their own identity and
additional information, and deliveries can be managed from the inside out. However, our
solution differs from that of Kärkkäinen et al. (2003) in that it builds on the securPharm
architecture with information-exchange channels, which is easy to adopt. Thus, our solution
applies an existing communication code and a reliable hardware infrastructure, which
facilitates the adoption of a drug-centric approach, as opposed to the installation of a
completely new peer-to-peer communication network.
SCV dashboard. Considering the interest of the case companies in an overall solution to
improve SCV, the authors further propose the implementation of an SCV dashboard that
merges all the information collected by current practical monitoring solutions applied within
the PSC, combining the functions of these solutions. Such a dashboard would allow the
continuous provision of collected information (Davenport and Brooks, 2004) and thereby
complete drug-centric monitoring without additional Auto-ID technology implementation.
The dashboard should be implemented on a central database, providing all PSC actors with
access to the information. However, this dashboard only combines information from current
practical monitoring solutions applied. This means that a logic function is missing and the
purely optical barcode or data matrix code do not ensure a sensor functionality. Moreover,
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accurate identification function is influenced by the fact that identification by barcode and
data matrix code requires line-of-sight scanning. Neither code allows the required bi-
directional communication function. Additionally, no information can be added at drug level
during the process activities because barcode and data matrix code are read-only (data storage
function). Thus, by constant scanning to feed information to the database, this solution would
only accomplish Req. 1.1 from Table VI. Moreover, the logical assignment of drugs to scan
points (locating function) does not allow for the provision of the required spatial position
information. In terms of secure identification, we propose redundant storage of information in
both the database and on the barcode or data matrix code. However, the shortcoming of such
an overall solution is that requirements other than 1.1, 2.1, and 2.2 from Table VI cannot
automatically be met in the way identified by the Auto-ID technologies of the current
practical monitoring solutions used. Consequently, the SCV dimensions position and status
quo are not realized by this solution.
However, the advantage of the SCV dashboard is that it allows the use of the central
database of the securPharm approach, even when securPharm is not implemented. The
ongoing securPharm initiative in Germany can facilitate implementation efforts of this
solution. With these modest efforts, also claimed by the pharmaceutical industry (Al-Kassab
and Rumsch, 2008), this solution can lead to an extension of the existing IT infrastructure,
instead of building a new solution. Furthermore, the dashboard solution can be implemented
in an open-loop system. To implement such a cross-actor system, an SCV dashboard should
be operated by a third party. This allows all the supply chain actors to access the dashboard
without requiring direct access to the in-house IT structure of one of the supply chain actors
involved (availability). Actors within the supply chain act as senders and receivers, with
previous authentication to ensure eligible access and data privacy. Moreover, the dashboard
can provide a useful possibility to involve the EMA because of its surveillance responsibility.

Discussion and concluding remarks


The current GDP guideline forces PSC actors to ensure and prove correct drug handling
across the entire supply chain. This study responds to this obligation by proposing solutions
for SCV enhancements based on Auto-ID technologies. To provide feasible solutions, our
study first presents an overview of SCV and its relationship with Auto-ID technologies. In
this context, the authors provide a conceptual framework with the dimensions availability,
identity, position, and status quo for the analysis of SCV. In connection with Auto-ID
functions, this framework helps to operationalize SCV and supports the selection of helpful
Auto-ID technologies. Based on this conceptual framework, the authors derived three Auto-
ID-based solutions: a securPharm approach with passive RFID tags, transport containers with
sensor nodes, and an SCV dashboard. To overcome all the identified requirements of the SCV
dimensions, our study theoretically recommends implementation of the sensor nodes’
solution. If actors require the continuation of their current practical monitoring solutions and
hazard deficiencies in the realization of SCV dimensions, the SCV dashboard provides an
overall solution in our studied PSC. However, our solutions demonstrate to researchers and
practitioners approaches to implementing drug-centric monitoring with stringent requirements
for accurate and secure identification and information handling.
Insights from the case study also show that current practical monitoring solutions (barcode,
data matrix code, data logger) that have already been implemented rather impede the
implementation of advanced Auto-ID technologies (RFID, RFID with sensor, WSNs).
Although advanced Auto-ID technologies help to enhance SCV, the case companies,
however, demanded an overall solution that takes into consideration those that have already
been implemented. This issue is also recognizable in previous studies (Kärkkäinen et al.,
2004; Mirzabeiki et al., 2014) and can therefore be seen as a barrier to SCV enhancements.
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Against this background, the analysis of our study has led to a dashboard solution that
synthesizes monitoring solutions that have already been implemented and combines their
functions to improve SCV. Similar solutions can be found in the studies of Houghton et al.
(2004), Mirzabeiki et al., (2014) and Sanders (2016) that deal with an analogical background.
In this context, we consequently argue the following propositions:

P1. Already implemented current practical monitoring solutions present a barrier to


enhancing SCV in a PSC according to legislative influence.
P2. A dashboard as an overall monitoring solution that synthesizes monitoring solutions
that have already been implemented will improve SCV in PSCs.

Furthermore, our empirical study shows that legislation with regulatory requirements clearly
influences process activities, and thereby creates requirements for the realization of SCV.
This insight confirms the finding of regulatory impact on SCV by Klueber and O’Keefe
(2013). Our study additionally demonstrates that object characteristics also present
requirements for SCV. For example, sensitivity, identity, and weight of drugs need to be
regarded when clarifying the status quo of drugs in the supply chain. Therefore, we also
support the works of Francis (2008) and Hafliðason et al. (2012), who emphasized the
consideration of object related characteristics as important for the realization of SCV. As our
analysis of the study shows, the resulting requirements for SCV of both legislation and object
characteristics demand an Auto-ID technology with advanced functionality and exclude the
use of current practical monitoring solutions. Our analysis demonstrates that sensor nodes of
WSNs based on their accurate and secure identification, automatic information logging,
locating, sensors, and logic functions are able to meet regulatory and object related
requirements for SCV. Thereby, our work corroborates current studies with similar
requirements (Hafliðason et al., 2012; Lang et al., 2011; Wang et al., 2015), which show an
increasing use of sensor nodes to enhance monitoring and visibility. Consequently, we argue
the following proposition:

P3. Object characteristics and regulatory requirements present requirements for SCV that
demand a sensor node based Auto-ID technology (WSNs) in order to achieve enhanced SCV.

Our study has certain limitations. Because of its complexity, it focuses on a special chain
within the PSC network. Therefore, care must be taken when extending the solutions to other
chains. Next, this study focuses on Germany; however, this is mitigated by the fact that the
GDP guideline is valid throughout Europe. In addition, the solutions do not claim to
encompass all Auto-ID technologies because we were unable to consider all the technological
possibilities.
Further research should investigate in more detail the implementation and costs (business
case) of the solutions. Moreover, other chains within the PSC network should be analyzed in
terms of SCV. Additionally, further studies can contrast our solutions and other monitoring
solutions of different industries to derive industry-specific context factors for monitoring
solutions (Al-Kassab and Rumsch, 2008; Holmström et al., 2010). Moreover, the derived
propositions from our empirical findings need further empirical investigation in other
pharmaceutical and industry supply chains. Regarding the SCV dashboard, possible
incentives to stimulate the exchange of information between actors must be investigated,
because the exchange of semi-sensitive information is always a critical concern. In this
regard, jurisdictional transaction flows should also be considered. Moreover, our SCV
dimensions and applied operationalization should be tested in terms of completeness to
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support SCV analysis. In addition to our focus on enhancing SCV using Auto-ID
technologies, further research can examine how to improve this aspect for in-transit services;
for example, drugs used in hospitals. For such services, Auto-ID technologies offer promising
control and visibility improvements in material flows (Arnäs et al., 2013).

Note
[1] A detailed process model is available upon request.

Acknowledgment
The authors are extremely grateful to the anonymous reviewers. We would also like to
sincerely thank the guest editors, Lise Lillebrygfjeld Halse and Trond Hammervoll, and the
senior assistant editor, Patrik Jonsson, for their support during the review process.

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Corresponding author
Marcel Papert can be contacted at: marcel.papert@uni-bamberg.de

About the authors


Marcel Papert (Dipl. Wi.-Ing.) is a PhD candidate in SCM, University of Bamberg, Germany.
His research focuses on the implementation of Auto-ID-based services (Internet of Things
services) in SCM, business ecosystems and business models. He is also a research assistant in
the Research Center for Business Models in the Digital World at University of Bamberg.

Patrick Rimpler (M. Sc.) is a consultant at Miebach Consulting - The Supply Chain Engineers
and will be a PhD candidate in Business Administration. His research focuses on the
internationalization of small and medium-sized enterprises and its success factors.

Alexander Pflaum (Dr rer. pol.-Dipl.-Ing., Friedrich-Alexander-University Erlangen-


Nürnberg, FAU) is Director of the Fraunhofer Center for Supply Chain Services SCS in
Nuremberg and Bamberg. Additionally he is responsible for the affiliated Center for Smart
Objects. In the past he has given lectures on technologies in logistics as well as on technology
and innovation management at FAU. Since 2011 he is Full Professor for Business
Administration, especially Supply Chain Management, at the Otto-Friedrich-University in
Bamberg. In 2014 he founded the Bamberg Competence Center for Business Models in the
Digital World together with other faculty members. In parallel to his scientific career he
conducted numerous development and consulting projects for retail, industry, public
institutions and logistics service providers. The focus of his research work is on the adoption
of smart object technologies such as radio frequency identification, wireless sensor networks
and real time location systems within the logistics industry. Currently he is working on
service engineering models and methods for smart object based supply chain information
services. He works with industry, speaks at international conferences, is involved in the
creation of international standards and has published his work in peer-reviewed journals.
Appendix – Interview guideline
(1) Introduction and explanation of research purpose
(2) Facesheet information
a. Name of the company, year of establishment, employees, revenue
b. Name and position of interview partner
(3) Process activities and SCV
a. What are the required process activities of this company for order fulfilment?
b. How does this company organize the handover of drugs to the following
supply chain stage?
c. How does this company measure and log drug temperature and identify
temperature deviation?
d. How does this company ensure drug authenticity and quality?
e. What is the average size of shipping unit?
f. What process related challenges and improvement potential does this company
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see in terms of SCV, giving consideration to the current GDP guideline?


g. What technologies does this company currently use to realize SCV?
h. Does this company use automatic identification technologies in the process
activities to realize SCV?
i. If so, how does this company apply such technologies?
(4) Possibility for further remarks and wrap-up
medical representative medical practice

hospital
pharmaceutical manufacturer

direct distributor
raw material supplier

hospital ward
pharmacy
service provider
logistics

pharmaceutical
packaging service provider

wholesaler

patient / consumer
pharmacy

retirement /
care center
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community

pharmaceutical
packaging manufacturer

mail-order
importer

pharmacy
(international)

pharmaceutical community
wholesaler
(international)

mail-order

Note: Studied PSC Drug flow with transport service provider (TSP)

Figure 1. Actors within the PSC network (Abramovici et al., 2010).


Identification
1
0.75
Logic 0.5 Locating
0.25
0

Data storage Sensors

Communication

Figure 2. Profile of required functionality.


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Table I. Definitions of SCV.
Author Definition
Kaipia and Hartiala “the sharing of all relevant information between supply chain partners, also over
(2006, p. 377) echelons in the chain.”
Barratt and Oke “the extent to which actors within a supply chain have access to or share information
(2007, p. 1218) which they consider as key or useful to their operations and which they consider will
be of mutual benefit.”
Francis “Supply chain visibility is the identity, location and status of entities transiting
(2008, p. 182) the supply chain, captured in timely messages about events, along with the
planned and actual dates/times for these events.”
Klueber and O’Keefe “Requisite supply chain visibility (RSCV) is the ability to provide and access
(2013, p. 300) information elements at a level chosen by the relevant supply chain stakeholders …”
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Table II. Conceptual framework with SCV dimensions and explanation.
SCV dimension Explanation
Availability Accessibility of information by all eligible supply chain actors;
Availability demands information sharing;
Identity Provision of identity information;
Level of detail depends on the demands of supply chain actors;
Example: identity at object level or identity of a complete shipment;
Position Provision of position information about an object within the supply chain;
Level of detail depends on the demands of supply chain actors;
Example: GPS information about an object or information about which supply chain
actor is currently responsible for which object;
Status quo Provision of information about the status quo of an object within the supply chain;
Information can entail object- and environmental-related aspects;
Example: information about transport, handling, storage, and temperature.
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Table III. SCV dimensions and related Auto-ID functions with degrees of performance.
Quantified degrees of performance
SCV Auto-ID 0.25 0.5 0.75 1
dimension function
Availability Communication Line of sight Availability at Complete cross- Integration into
base stations or linkage telecommunication
scan points (bi- networks
directional)
Data storage One Data volume in Data volume in Data volume in
identification kilobyte range megabyte range gigabyte range
number
Identity Identification Identification Identification of Identification of Identification of
of charges outer packaging product category products
Position Locating Logical Room-level Localization in Localization in
assignment localization metre range centimeter range
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Status quo Sensors Single sensor Up to five More than five Nervous system
sensors sensors
Logic One event More than one Business logic Artificial
event intelligence
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Table IV. Functionality profiles of Auto-ID technologies from reviewed monitoring solutions.
Auto-ID technologies
Reviewed Kärkkäinen et al. (2003); Kärkkäinen et Mason et al. (2012) Hafliðason et al. (2012)
monitoring al. (2004); Martínez-Sala et al. (2009);
solutions Arnäs et al. (2013); Hinkka et al. (2015)

RFID RFID with sensor WSNs

Identification Identification Identification


1 1 1
0.75 0.75 0.75
Logic 0.5 Locating Logic 0.5 Locating Logic 0.5 Locating
0.25 0.25 0.25
0 0 0

Data storage Sensors Data storage Sensors Data storage Sensors

Communication Communication Communication

Reviewed DHL (2015) Hansen and Gillert (2008) securPharm (2014)


current
practical Data logger Barcode securPharm with data matrix code
monitoring
solutions
Identification Identification Identification
1 1 1
0.75 0.75 0.75
Logic 0.5 Locating Logic 0.5 Locating Logic 0.5 Locating
0.25 0.25 0.25
0 0 0

Data storage Sensors Data storage Sensors Data storage Sensors

Communication Communication Communication


Table V. Overview of case companies.
Case Actor within our focused PSC Position of experts Employees Revenue
in interviews (2013) (2013)
1 Pharmaceutical manufacturer Head of supply chain < 250 > 1000 MEUR
2 Transportation service provider CEO < 250 > 1 MEUR
for wholesalers and pharmacies
3 Logistics service provider Head of quality management > 1000 > 100 MEUR
4 Pharmaceutical manufacturer Head of supply chain > 50 000 > 10 000 MEUR
5 Pharmaceutical manufacturer Head of supply chain > 10 000 > 10 000 MEUR
6 Logistics service provider CEO < 250 > 1 MEUR
7 Logistics service provider Head of supply chain and > 1000 > 1 MEUR
quality management
8 Pharmacy CEO (Pharmacist) < 250 > 1 MEUR
9 Pharmacy CEO (Pharmacist) < 250 > 1 MEUR
10 Pharmaceutical wholesaler Head of supply chain > 1000 > 1000 MEUR
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Table VI. SCV dimensions and requirements.
SCV dimension Requirement (Req.)
Availability 1.1 A central database where information is stored and accessible to actors;
1.2 Automatic logging of transport and temperature information in a database and at
drug level;
1.3 Information exchange between database and drug level;
Identity 2.1 Secure and accurate identification at drug level;
Position 3.1 Spatial position information;
Status quo 4.1 Temperature sensing and a record of temperature data;
4.2 Verification of assignments, comparison of current and expiration date,
verification of classifications (i.e. verifying drugs, pallets, and storage space; i.e. a
comparison of container and drug destination);
4.3 Recognition of unauthorized drug removal with the associated date and position.
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