Chapter: 06

Uses & Impact Of Technology

In Pharmaceutical Industry
6.1 Technological advancements in pharmaceutical industry:
We all know the contribution of technology is always unimaginable regardless of any industry
on any sectorial differences. As biology and technology become ever more closely intertwined,
new opportunities are emerging to improve healthcare through the use of innovative digital
technologies. Here's a glimpse at some of the great strides that innovation teams within
pharmaceutical companies are making in the exciting field of digital health.

6.1.1 What is Pharmaceutical Technology?

Pharmaceutical technology is application of scientific knowledge or technology to pharmacy,
pharmacology, and the pharmaceutical industry. It includes methods, techniques, and
instrumentation in the manufacture, preparation, compounding, dispensing, packaging, and
storing of drugs and other preparations used in diagnostic and determinative procedures and in
the treatment of patients.

6.1.2 Why it is important?

Here we are talking about innovation, technology, research and development status of
pharmaceutical industry both in perspective of global and Bangladesh scenario. This is one of
the most important issues because:

Technological Efficient production Sales revenue, cash fow,

advancements and material turnover rise
Good R&D management Large scale of production
Global comptency Reduced production raises volume of exports
costs and industry capacity
Good ownership of
patent and copyright Higher workfoce Industry's overall financial
dealings skills condition being good
Better outsourcing or Efficiency, learning Contribution to GDP rises.
inter country effects, mass Higher standard of living
improvements in customization and economic growth
production capacity achieved
Improvement in
producing quality
products and
adding newer
features
We live in an age in which technology is moving at a rapid pace, creating new fields and
disrupting existing models and processes. From a career standpoint, staying abreast of new
innovations in pharma can be extremely beneficial, helping us to adapt to change, seize new
opportunities and focus on developing the skills that we will need in the future. One of the
most prominent quotation can further more explain how much important it is to work more on
technology for taking pharmaceutical sector to a continuously better position. As the famous
guy said, Steve Jobs predicted "The biggest innovations of the 21st century will be at the
intersection of biology and technology", a movement referred to as digital health or mHealth
(mobile health).
This forecast by the late Apple CEO appears to be on track as consumer technologies such as
mobile phones and wearable devices are already beginning to revolutionize the wider health
industry. These and other technologies are also proving to have great potential in
pharmaceutical research and development, and are being adopted by pharma companies to
assist in developing new drugs as well as improving patient outcomes and increasing patient
access through reduced costs.

6.1.3 Technological status of Bangladesh’s Pharmaceutical Industry

We don’t find much technological developments in this sector even before some years back.
But in recent years, we see a lot of changes and developments are taking place here. The major
points to be noted are:
 It is mandatory to all the local and foreign companies to follow good manufacturing
practices (GMP) as per WHO recommended guide line. Although, top and medium
level companies strictly follow GMP and possess all high-tech facilities in their
premises, but they do not have R&D facilities in real sense.
 The top 30 local companies have well-equipped product development (PD) department
instead of full-fledged R&D. Recently some top pharmaceutical industries are
producing high-tech biopharmaceutical products have started real R&D activities in a
limited scale . Only few of the APIs producers have full-fledge R&D facilities. Most
of them are manufacturing under technology transfer from India and China.
 There several hundred registered companies but none of them have appropriate
research and development (R&D) activities to standardize the herbal drugs to ensure
their quality, safety and efficacy
  Quality control and methods of preparation of these medicines (except herbal) are done
by primitive methods
 There are good numbers of experts working on medicinal plants different institutions
but none of these are operated in an integrated way to develop and establish medicinal
flora as safe and effective drugs.
 Among all the universities, the research facilities on medicinal plants in the Dept. of
Pharmaceutical Chemistry of Dhaka University are well advanced but do not have
R&D facilities
 There are lack of collaboration between local manufacturers and researchers of
public/private universities to promote R&D activities.
 We have enough foreign trained expertise in this field but due to lack of proper
financial support, establishment and conduct of R&D activities focusing the need of
the country is still far behind.

Pharmaceutical sector is very technological intensive and far more innovative in terms of new
product/process innovations when compared to low technology sectors such as textiles and
agro -processing. But in the context of LDCs, it confirms the extensive relationship between
firms and the knowledge systems they are entrenched in. The difficult state of the domestic
knowledge system in country, forces firms operating in what is normally a high-technology
sector to focus on manufacturing and excludes the more knowledge-intensive activities from
their reach.
This lack of capacity to locally produce APIs reduces the competitiveness of the firms
enormously, since between 30 and 50 per cent of the production price of the drugs is taken over
by the expenses of securing APIs from external sources. The top local firms (around six in
total) are trying to secure skills and scientific infrastructure in order to venture into API
production and reverse engineering. Lacking scientific infrastructure includes missing human
resources as well as the incapacity of domestic research and development institutes, (RDIs)
and universities in assisting the firms in developing these chemical synthesis skills due to
under-funding of research, disillusion of scientists and researchers and lack of a cogent focus
amongst core university faculties that do work on medical sciences. This disarticulation
between various components of the domestic knowledge systems illustrates a prevailing
phenomenon that prevents effective learning and absorption by the enterprise sector in most
LDCs. Most exporting firms in the survey pointed out cheap labor costs as their main advantage
in the international markets, but even the biggest firms like Square Pharmaceuticals were
skeptical about whether they could capture markets in other African and Asian countries on the
basis of just cheap labor when they did not possess the economies of scale and reverse
engineering skills on par with their Indian counterparts.
So, to enjoy even higher efficiency and growth in the pharmaceutical sector more and more
focus should be given to improvements in technology to keep competitive capacity favorable
with regard to global scenario of pharmaceutical sector.

6.2 Technology-past and present situation in pharmaceutical

industry:
Over the past 40 years, information technology has had a major impact on the working lives of
millions of people. Many industries have embraced computer technology because of the
benefits of automated information processing. These include enabling routine, repetitive and
monotonous tasks to be conducted with consistent accuracy; standardisation and consistent use
of terminology and nomenclature; and mass customisation (the capacity of information
technology to provide services to a large population, yet in a way that can be customised to the
individual).For prescribers and pharmacists, IT can enable the storage of structured patient
records, facilitate the electronic prescribing, dispensing and administration of medicines,
automate the handling of medicines in the supply chain and provide tools for monitoring the
efficacy and safety of medicines in use. IT can therefore improve patient safety, enable
professionals to provide high quality care and help patients make the most of their medicines.

6.2.1 Making the most of systems

Pharmacists are already using IT systems to support their daily work and, when considering
the IT requirements for emerging working practices, pharmacists should consider what
functions could be provided by systems that they already use. For example, all pharmacies use
pharmacy management systems for medication records, dispensing, labelling, ordering and
stock control. However, many pharmacies do not use all of the available functionality of their
system, for example, modules to handle patient-centred services, such as medicines use reviews
or prescription interventions. Pharmacists should also make the most of services that are
available in their locality, for example, electronic prescription service release 2. Adoption and
use of EPS release 2 in areas where it is available has the potential to make dispensing and
reimbursement processes more efficient for community pharmacists and the nomination
process may help pharmacists to secure prescription business. Access to patient record systems
will assist pharmacists with professional decision-making in providing patient-centred
services. For example, the summary care record is now available in many areas, and has been
shown to be beneficial for hospital pharmacists for medicines reconciliation. In future, it may
be used by community pharmacists, for example with MURs and emergency supplies. As
pharmacists deliver more patient-focused services in future, they will increasingly use national
and local patient record services to do so.

6.2.2 Six Tech Trends that are shaping the Pharmaceutical Industries
Life sciences companies face unprecedented challenges as revenues come under pressure as a
consequence of pricing pressures caused by healthcare reforms and austerity measures,
increased competition, and challenges in bringing new drugs and other products to market.
They are responding by focusing on growth opportunities in emerging markets, pursuing
breakthrough innovation through collaboration with industry and academic partners,
challenging and revolutionizing the traditional sales, marketing and research and development
(R&D) operating models and focusing on operational efficiency. Shifts in the attitudes of
patients and healthcare professionals and emerging technologies are changing the relationship
life sciences companies have with their traditional customers and creating new opportunities
for collaboration, which will have a fundamental impact on the future success of businesses.
In a recent Accenture report, Technology Vision: What It Means for Life Sciences, the firm
found the following six technology trends will continue to influence the pharmaceutical
industry over the next three to five years.

#1 Context-Based Services: Where You Are and What You’re Doing

Today, location-based capabilities and wide-scale use of smart phones and other 3G and 4G
devices have helped pharmaceutical companies find new ways to engage patients and provide
them with useful services that can improve quality of life. For example, the makers of Clarityn
created an app which provides users with detailed information about local pollen count and
where to find nearby medication to help ease seasonal allergy symptoms.
Beyond apps, technology can be used to collect patient data in real time. Imagine, for instance,
a patient’s heart-rate monitor that could detect erratic heartbeats and send this information to a
smart phone. The devices could then “talk” and automatically make an emergency call to a
specified healthcare provider. This new generation of wireless sensors opens up a whole world
of potential for life sciences companies—for gathering targeted information for research,
efficacy and compliance. “These technologies can help bring products to market more quickly
by allowing patients to provide real-time data right from their own homes,” said Anne, Global
Managing Director of Accenture’s Life Sciences industry group.

#2 Using "Big Data" for New Value

Similar to other major industries, the pharmaceutical industry is learning how to utilize “Big
Data,” the catchall term for the explosion of data and technologies emerging to support it. In
healthcare, we’re seeing electronic medical record (EMR) data coming together with genomic
and genetic data; financial data; and patient-reported data to deliver insight into which therapies
provide the highest overall value to patients and healthcare systems at the lowest cost. This
information will be especially vital under healthcare reform and the upcoming move to
accountable care organizations (ACOs). ACOs encourage better patient outcomes by
reimbursing healthcare providers based on quality outcomes and measures. Using EMR data
and e-prescribing information, physicians and insurance companies can better track patient
outcomes over the long-term, a critical element for providers to demonstrate their performance
and therefore be properly reimbursed. Pharmaceutical companies will need to collaborate on
this front as well and use this targeted data to improve areas such as drug development, meet
the needs of insurers and provide compelling evidence of a drug’s benefits.

#3 Industrialized Data Services

While organizations continue to hunt for new and useful data, they are also looking for
opportunities to share it. Enter: data services. Traditionally data has been used in silos, but data
services helps to find opportunities to use data in many different ways, unlocking far more
potential. For example, in R&D, establishing data services enables the use of clinical-trial data
in trial simulations, which can yield findings at lower cost and with lower risk.
Data services will also enable R&D organizations to organize data from multiple outlets,
including contract research organizations (CROs), academic institution, research lab partners
and public health institutes. This allows for creative new solutions and a greater understanding
on the efficacy and safety of drugs and devices.
#4 Pharma Gets Social
Over the years, social media has been a highly sensitive area for life sciences companies, which
are often bound by strict marketing and FDA regulations. But some companies are beginning
to experiment with the new medium. For example, drug maker Sanofi has emerged as a social
media leader by building a Facebook community for diabetes sufferers who connect online to
share their experiences with the disease.
“These types of forums can help our clients better understand their customers’ perspectives,
experiences and problems, while also providing information on current treatment trends and
patterns,” said Anne. “They can improve and focus on the health and wellbeing of the patients
they serve, by engaging with customers and providing better customer service through an
online presence.”
#5 Focusing on the Cloud to Cut Cost and Improve Business Functions
To date, the cloud market has mainly served as a tool for sales and marketing teams within
most pharmaceutical companies. But that’s quickly changing. Today, the cloud market is
adapting to meet the needs of all areas within life sciences and has shown to be particularly
helpful in overcoming IP issues, security issues and has allowed many companies to cut down
on operational costs. In fact, drug maker Roche recently announced it was moving to Google’s
cloud-based applications, including Gmail and Google Docs, to support its more than 90,000
employees globally. The company believes it will enable employees to collaborate strategically
without requiring large expenditures and potentially disruptive upgrades.

#6: Growing Security Concerns

As life sciences organizations begin to adopt cloud, social media and mobile technologies in
order to access and share information, they also face potential new security threats and
breaches. To deal with these complex and ever-changing array of threats organizations must
move from simply monitoring and collecting data to understanding it and visualizing new
attitudes and anomalies. As an example, companies could identify a possible internal threat by
analysing activity patterns of a suspect employee’s time spent downloading confidential data,
which would in turn trigger a compliance check.
Accenture predicts that to better understand these risks and to detect attacks, organizations will
increasingly turn to data platform technologies that provide data access and aggregation via
services. The data platform will handle secure access to large volumes of fast-changing data
that many companies are unable to manage in house.
6.3 Main uses of technological mechanisms in this industry

6.3.1 The power of the internet

The internet has been widely adopted for business and social communications. In future, as
internet use becomes universal, there may be an increase in the number of internet pharmacies,
and use of the internet to display and disseminate information on medicines and health from
pharmacies. Currently, secure web-based platforms are available from various providers to
support enhanced pharmacy services and public health initiatives. The use of these will increase
and also web platforms will be used as a communication portal to make information available
to pharmacists from other care settings.

6.3.2 Electronic prescribing and discharge

Electronic prescribing (EP) systems automate prescribing, supply and administration of
medicines in hospitals, where they have been shown to reduce medication errors and have a
major impact on patient safety. However, the effect on error reduction is dependent on system
design and a poorly implemented system can actually increase error rates.
Timely and accurate transmission of a patient’s discharge prescription from secondary to
primary care is important to ensure seamless patient care, and also to prevent errors arising
from miscommunications. Recently, many hospitals have adopted electronic discharge systems
(sometimes as a “quick-win” compared with a whole-hospital EP system). However, these
systems may have inadequate decision support functions, and data fields that are not in a
standard format. Furthermore, they route the discharge information to GPs, not to community
pharmacists. There are a number of local and national initiatives being developed to address
these issues, such as the NHS Connecting for Health Electronic Discharge Implementation
Toolkit with standard discharge headings, schemes such as the East Lancashire “Refer to
pharmacy” system, designed to ensure that community pharmacists are in the discharge
communication process and the Royal Pharmaceutical Society’s standard pharmaceutical care
record programme.

6.3.3 Barcode medicine identification

Barcode identification of medicines has been used with EP systems and has been shown to
reduce medicine administration errors, as well as improve the completeness of the medication
history. However, barcode medicine identification at the point of administration is an
interruptive process and, for this reason, health professionals often develop “work arounds” to
circumvent barcode scanning.
The Falsified Medicines Directive (FMD), due to be implemented in 2017, calls for unique
identification of medicines at the point of dispensing, in order to combat counterfeiting.
Although the exact UK system to support FMD has not yet been developed, this process is
likely to involve barcode scanning of medicines and will therefore have a major impact on
pharmacy workflow.

6.3.4 Automated dispensing

Robots have been used in logistics and distribution for many years, but only recently in
pharmacy. In 2001, the Audit Commission’s “Spoonful of sugar” report advocated the use of
automation to transform pharmacy services and, since then, many UK hospitals installed
dispensary robots. Pharmacy robots have been shown to reduce the incidence of dispensing
errors, improve the speed and efficiency of the dispensing process, and optimise use of space
in the pharmacy.
Robot use in community pharmacy in the UK is still relatively limited. However, robots have
the potential to handle high volumes of dispensing in community pharmacies, or dispensing
“hubs”, and to release pharmacists to develop and deliver patient-centred services. As newer,
smaller and more efficient machines become available, robot use in all sectors of pharmacy is
likely to increase. Similarly, automated methadone dispensing machines. offer accuracy and
efficiency in the laborious methadone dispensing process and their use is likely to increase,
too, especially in pharmacies with a high volume of methadone dispensing.
The use of electronic ward cabinets is the next level of automation in hospitals. These have
been shown to provide benefits such as reduced number of medication errors, reduction in
number of missed doses, supply delays and stock outages, and reduction of stock-holding and
wastage.
However, installation of ward cabinets constitutes a considerable expense, a major
implementation project and a significant change in working practice for both pharmacy and
nursing staff. For these reasons, ward cabinets have not been installed in many UK hospitals to
date.
6.3.5 Mobile technology
The use of mobile telephones is widespread in society. Some pharmacies are using text alerts
to remind patients that repeat prescriptions are ready or to offer services, but sophisticated apps
have been developed for disease monitoring, for example, recording of peak flow readings in
asthma, monitoring of blood glucose levels, medication adherence support and health
education. These apps will have a greater impact on pharmacy practice in future.

6.3.6 Adherence monitoring

Various technologies are now available to support approaches to adherence monitoring. A
number of vendors have developed “smart” packaging, where a microchip-containing tablet
blister pack is able to monitor when doses are popped out (not necessarily taken) and prompt
the patient to record side-effect monitoring information for the medicine in question. These
data can then be transmitted to a mobile telephone or tablet device.

6.3.7 Telecare
Telecare involves the use of digital communications technology (audio and visual) to provide
healthcare consultations and services to patients remotely at home. Telecare has various
potential benefits: it puts patients at the centre of their care and supports personalised medicine;
it improves access to healthcare by reducing the need for hospital attendance (for people with
poor mobility, or those in remote areas); and it can reduce the travelling times and costs of
healthcare professionals. However, the exact benefits provided by telecare vary between
different applications and care scenarios, and, at present, the literature suggests that more
evidence of outcome benefits, and more cost-effectiveness data are required to justify further
investment in telecare. In pharmacy, use of remote consultations, together with EPS release 2
and an internet pharmacy supply service, could transform the way that pharmacy services are
provided. However, adoption of telecare in pharmacy would be dependent on the availability
of reliable communications and integration architectures, the willingness of pharmacy
operators to invest in these and also a critical mass of domestic use of digital technologies in
all patient demographics.
6.4 Impact of technological revolution in the pharmaceutical
industry:

Lately everyone has been talking about the fact that the world is in the midst of the 4th
industrial revolution. This revolution, or technological revolution, has kicked in during the last
few years, and it is here to stay. It has created massive hype and advancements in many fields,
and is changing the way manufacturers operates.
Technological Revolution is all about digitalization and automation of the manufacturing
world. While manufacturing used to heavily rely on the human factor, industry 4.0 is based on
autonomous, computerized processes. This automation theme utilizes data and analytics for
improving manufacturing processes, management decision making processes and quality
assurance.

6.4.1 Continuous manufacturing in the pharma industry

The pharma industry has been using batch manufacturing for more than 50 years. However,
the traditional batch process method has been proved to be a lengthy one: after each step in the
process the production is typically stopped, so that the substance could be tested for quality
assurance. Sometimes during these "hold times" the material may be stored in containers or
even shipped to other facilities in other countries, to complete the manufacturing process. Each
break increases lead time and may increase possibility of defects and error.
But the future of the pharma manufacturing is approaching. In 2016, the FDA has released a
blog entry, stating that it is encouraging pharmaceutical manufacturers to transition from batch
manufacturing to continuous manufacturing, due to its many advantages.
This encouragement also comes in a specific timing – today, we are entering an era of precision
(personalize) medicine, "when drugs must be made with unique features and provided more
quickly to patients in need.".
In order to manufacture personalized drugs, pharma factories no longer need to manufacture in
big batches but in small ones, in a manner suitable to a small group of people that need a certain
medicine in a certain dosage. Batch manufacturing is definitely not the solution to these needs,
but the connected, smart, flexible and precise continuous manufacturing.
Fig. 2: Batch manufacturing vs. continuous manufacturing in pharma (Source: FDA, 2017)
In the pharma industry, continuous manufacturing is all about moving the substances nonstop
within the same facility, thus eliminating hold times between the different steps in the process;
the materials are fed through an assembly line of fully integrated components. Continuous
manufacturing "saves time, reduces the likelihood for human error, and can respond more
nimbly to market changes. It can run for a longer period of time, which may reduce the
likelihood of drug shortages.".
In addition to the regulator's encouragement to move on to precise medicine, the market forces
also make their impact on the pharma industry, requiring it to implement the industry 4.0
technologies and continuous manufacturing: the rising competition as generic drugs enter the
market; the demand for high drug quality; prolonging the shorter drug life cycle; and the need
to reduce the high costs of batch manufacturing.