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PRESERVING EFFICACY OF TEMPERATURE SENSITIVE MEDICINES- LOGISTICS MANAGEMENT
IN PHARMACEUTICAL SUPPLY CHAINS
byZAIN NASIR
A thesis submitted in partial fulfillment of the requirementsFor the degree of Master of Business Administration
To Office of Research, Innovation & Commercialization(formerly IQRA University Research Centre - IURC)
At Iqra UniversityMain campus, Karachi
Karachi, PakistanJULY, 2015
Preserving Efficacy of Temp. Sensitive Medicines 2
Acknowledgments
This Thesis Report is the result of constant efforts combined with hard work and dedication, a comprehensive research on the subject, i.e.
‘PRESERVING EFFICACY OF TEMPERATURE SENSITIVE MEDICINE – LOGISTICS MANAGEMENT IN PHARMACEUTICAL
SUPPLY CHIANS’.
This report has proved to be an extremely informative and learning experience. For this, I would like to thank Almighty Allah & I would also like to thank my Thesis Supervisor; Dr. Masood Sabzwari, for providing me with this opportunity, as well as his guidance in the light of his vast
experience.
Preserving Efficacy of Temp. Sensitive Medicines 3
ii ii
Preserving Efficacy of Temp. Sensitive Medicines 4
Abstract
In this research we have investigated the variables affecting the logistics cost
of temperature sensitive medicines. We have explored the Pharmaceutical industry of
Karachi, Pakistan and tried to find out that the factors relating to product
manufacturing, packaging and transportation that whether they play a vital role in
preserving the efficacy of temperature sensitive medicine. The study focuses on the
several factors such as Active Ingredients, Storage and Logistics. Each of these
factors has been discussed in sufficient detail. The data collected from the respondents
was tested using Sample T-Test technique, respondents were chosen irrespective of
age, gender but try to focus on working professionals. In total a sample size of 107
have been taken from different industrial sector of Pakistan as well as students of
Supply chain management. Our Results represent that all the proposed hypothesis
relating to the above stated independent variables play a significant role in preserving
the efficacy of temperature sensitive medicines except the use of active ingredient in a
product. However active ingredient plays a vital role in the medicine but they are
properly check from different biological test by the manufacturing unit therefore there
is very less chance that efficacy would be affected at the time of manufacturing, Thus
it is proved that the preservation of product will be affected if the storage and logistics
would not be managed properly. It is the responsibility of both transporter and the
consignee to take care of their shipments according to the requirement otherwise it
would be harmful for the consumer. The study is also helpful and beneficial for
transporters/freight forwarders and distributors as well as the medical staff of different
stores, hospitals of Karachi, Pakistan.
Preserving Efficacy of Temp. Sensitive Medicines 5
Table of Contents
S.NO. DESCRIPTION PAGE NO.
1. Acknowledgements …………………………………………… ii
2. Abstracts ……………………………………………………… iii
3. List of Tables ……………………………………………….. vi
4. List of Figures ……………………………………………….. vi
5.
Chapter 1: Introduction1.1 Overview ………………………………………………..1.2 Problem statement ………………………………………1.3 Background, Objectives and Significances of the Study..1.4 Outline of the study …………………………………….1.5 Definitions ………………………………………………
1
6.
Chapter 2: Literature Review2.1 Effects of Temperature on Sensitive Medicine………..2.2 Classification of Temperature for Storage & Transportation.2.3 Cold Supply Chain …………………………………..
2.3.1 Temperature Control of Raw Material……….2.3.2 Packaging & Labeling of Temperature Sensitive
Medicine. ………………………………………2.3.3 Temperature Control in Transportation & Distribution.
2.4 Problems in Protecting Temperature Sensitive Medicine in Pakistan …………………………………….
2.5 Development of Hypotheses
5
7.
Chapter 3: Research Methods3.1 Method of Data Collection ……………………………3.2 Sampling Technique ……………………………………3.3. Sample Size …………………………………………..3.4 Instrument of Data Collection ………………………….3.4.1 Validity and Reliability Test …………………3.5 Research Model Developed ……………………….……3.6 Statistical Technique ……………………………………
13
8.
Chapter 4: Results 4.1 Findings and Interpretation of the results ……………… 4.2 Hypotheses Assessment Summary…………………..…
16
Preserving Efficacy of Temp. Sensitive Medicines 6
iv
Preserving Efficacy of Temp. Sensitive Medicines 7
Table of Contents
S.NO. DESCRIPTION PAGE NO.
9.
Chapter 5: Discussions, Conclusion, Policy Implications and Future Research5.1 Discussions ………………………………………….…..5.2 Conclusion ……………………………………………..5.3 Implication ……………………………………….……..5.4 Future Research ………………………………………..
19
10. References …………………………………………….……….. 22
11. Appendix ……………………………………………………….. 24
v
Preserving Efficacy of Temp. Sensitive Medicines 8
List of Tables
S.NO. TABLES Page Number
1 Table 2.1: Effect of temperature and duration of exposure on medicine potency. 7
2 Table 2.2: International Classification for Storage & Transportation. 7
3 Table 3.1: Case Processing Summary 14
4 Table 3.2: Reliability Testing 14
5 Table 4.2: One-Sample Test 17
6 Table 4.3: The outcome one-sample T-Test 18
List of figures
S.NO. FIGURE Page Number
1 Figure 3.1: Conceptual Research Model (Self Developed) 14
vi
Preserving Efficacy of Temp. Sensitive Medicines 9
CHAPTER 1: INTRODUCTION
1.1 Overview
Appearance of poliovirus among the children who have received several doses
of the vaccine among infants is clear evidence that the efficacy of the medicine is
being compromised. Polio vaccine requires storage temperature of 2-8 oC, Very cold
temperature is also undesirable and if the vaccine becomes frozen it needs to be
discarded (Hartee, 2010).
Pakistan has a hot climate where temperature in the shade often exceeds 40 oC. If left
unprotected, temperature inside a van or truck could exceed 50 oC during
transportation. Most normal pharmaceutical products require storage at ambient
temperature of 20 oC (Bishara, 2003), others require even lower temperatures of
around 4o C, and still other requires even lower temperatures. Maintaining a cool
chain from production to the time of administering the medicine is therefore important
in maintaining the efficacy of pharmaceutical products.
Logistics of pharmaceutical distribution and ensuring that the medicines are kept at
the temperature required for their storage is a challenge of significant proportion in
Pakistan. Pharmaceutical companies have the responsibility of ensuring that
transportation of medicines is carried out in vehicles that can maintain required
temperature. In addition, the pharmaceutical product storage at distributors and
chemist also needs the required refrigeration (Bishra, 2006). The highly sensitive and
expensive medicines are often supplied through a limited number of reputable stores
or by pharmaceutical company’s sales representative. Insulated packing and even ice
pads are often used to transport these medicines (Eli Lilly Forteo, 2012).
Cold chain maintenance is receiving considerable attention of major pharmaceutical
companies but downstream supply chain requires much more attention to ensure that
Preserving Efficacy of Temp. Sensitive Medicines 10
the product reaches the patient without suffering damage due to problems in cool
chain process.
This research project investigates the variables affecting the logistics of
temperature sensitive products. Impact of product packaging, temperature monitoring
in storage and transportation are some of the aspects that may have an adverse effect
on the efficacy of products.
1.2 Problem Statement
Ensuring efficacy of medicine until it is administered to the patient is the
responsibility of the pharmaceutical companies. The patient paying large amounts for
purchasing the medicines deserve the medicine that meets the specifications. It is also
important for the reputation of the pharmaceutical company. The challenges faced in
achieving this goal are the subject of this research study. The problem to be studied is:
Preserving Efficacy of Temperature Sensitive Medicines- Logistics Management in
Pharmaceutical Supply Chains
1.3 Background, Objective and Significance of the Study
Pakistan is not a social welfare state and healthcare is mostly left to a few
government hospitals and private health care institutions. Even in government
hospitals, people are asked to buy the required medicine from the open market. The
medicines and health care for serious illnesses can bankrupt a family. Even with the
high costs the medicine are sometime useless, as they have lost their efficacy due to
improper handling and storage at inappropriate temperatures.
Large multinational pharmaceutical companies are very responsible in distribution of
their medicine for a variety of reasons such as to avoid counterfeiting and avoiding
exposure to unacceptable temperatures etc. Most large companies have their own
Preserving Efficacy of Temp. Sensitive Medicines 11
distribution network and claim to be delivering medicines to chemist shops in
excellent condition. The storage at chemists is not in their control. Power outage due
to load shedding makes the refrigerators useless and medicines may loose their
efficacy during storage and onward transportation to the patients. The objective of this
study is to explore the strategies required to protect the medicine from excessive
temperatures and protect the efficacy of temperature sensitive medicines.
The study would be helpful in guiding both the pharmaceutical companies and the
consumers to ensure that they the patient receives full benefit of the medicine the
patient receives.
1.4 Outline of the study
This research study explores the important area of maintaining a cool chain to
protect the integrity and efficacy of temperature sensitive medicines.
This thesis is divided into five chapters. Chapter-1 begins with a justification of this
research and argues that improvement in logistics of temperature sensitive medicines
is essential for protecting the interests of pharmaceutical companies as well as the
patients. Chapter-2 presents a literature review on the subject and discusses issues
involved in maintaining a cool chain in various stages of transportation and storage.
The research hypotheses have also been developed in the chapter. Chapter-3 presents
research methods and statistical analysis applied to the primary data collected through
a questionnaire-based survey.
Chapter 4 presents the results of the data analysis and the final chapter (Chapter-5)
discuss the results and conclude the outcome of this research.
Preserving Efficacy of Temp. Sensitive Medicines 12
1.5 Definitions
Cold Chain
Logistics (CCL)
Madhukar, Kumar, & Khattri (2013) describes Cold Chain
Management as the set of connections of facilities and
distribution choices that performs the regular supply chain cycle,
but with temperature and moisture control throughout SCM
process.
Cold chain management is the process of scheduling, executing
and calculating flow and storage of medicines, related services
and information (Dekker, 2011).
Efficacy In pharmacology efficacy determine as the highest possible
reaction possible from drugs.
Preserving Efficacy of Temp. Sensitive Medicines 13
Chapter 2: Literature Review
Medicines require storage at temperature at which they can retain their
efficacy until their expiry date. Coleiro (2012) studied medicines normally available
at large chemist shops and found that out of the 1794 medicines included in the study
that are recommended for room temperature storage, 1039 required storage below 25
OC. Nearly 25% (414 medicines) recommended storage temperature of 30 OC and 334
did not mention any specific temperature (Coleiro, 2012).
The room temperature of 25 OC might be considered normal for some of the European
countries but in most other part of the world including Pakistan temperature under the
shade often exceeds 40 OC. In other countries, room temperature if not controlled can
be near freezing. It is therefore important to protect even normal “room temperature”
medicine from normal ambient temperatures in very hot and very cold climate.
During transportation, temperature inside a close container can reach in excess of 50
OC. Even ordinary across the counter medicines lose their efficacy at these kind of
extreme temperatures (Konradaug, 2011).
2.1 Effect of Temperature on Sensitive Medicines
In addition to normal medicines, vaccines, specialty medicines, blood and its
derivative and many other medicines are much more sensitive to temperature and
require cold storage (Coleiro, 2012). Vaccines such as Measles, Mumps and Rubella
(MMR) are sensitive to temperature and sunlight (WHO, 2004). The loss of potency
is permanent and the vaccines are considered damaged.
World Health Organization assessment report (WHO, 2009), shows that out of 70
countries only 29% countries follow the minimum requirements of temperature
Preserving Efficacy of Temp. Sensitive Medicines 14
control in medicine storage and transport. Due to improper arrangement of cold chain
logistics, shelf life is shortened and in worst case, products could be ruined. Biologics
are most stable at 2-8ºC. Vaccines, insulin, and blood pressure products have high
risk, and at sub-zero temperatures may permanently denature proteins which causes
loss in efficacy. Bishra (2006) mention that more than $400 billion of pharmaceutical
that were sold in 2003, nearly10% were biopharmaceuticals, given than these are
temperature sensitive medicines, clearly shows that the cold chain has an important
part of pharmaceutical supply chain.
For vaccine transportation and storage, Madhukar, Kumar, & Khattri, (2013)
emphasize that temperature should be maintained between 0ºC and + 8ºC because
vaccines losses their potency when exposed to heat while its outward appearance
remains unchanged. Risk of damage is increased where relative humidity (RH) level
is comparatively high such as cold rooms and cold transport because of humidity they
become softened and collapse (Taylor, 2003).
Sarley (2013) reported a measles outbreak in Ghana as the vacines administrated was
compromised because of poor cold chain and another campaign had to be launched at
extra cost.
Effect of temperature on medicine is further demonstarted by the research work of
Bhadra et al (2004). They show the effect of temperature and multilayer capsule
material on ciprofloxacin hydrochloride, an antibiotic that requires storage at 4 1 0C
(Table 2.1). When exposed to temperatures of 25 1 0C and 50 1 0C, the potency of
medicine after storage periods fell with increased temperature exposure over longer
duration.
Table 2.1:
Preserving Efficacy of Temp. Sensitive Medicines 15
Effect of temperature and duration of exposure on medicine potency (Bhadra et al 2004)
LBL-1 refers 1 to one kind of capsule and LNL-2 refers to a multilayer capsule.
2.2 Classification of Temperature for Storage & transportation
Reed (2005) classifies temperatures for transport/storage as given in Table 2.2
Table 2.2:
International Classification for storage & Transportation (Reed, 2005)
Category International Storage & Shipping Requirements.(0C/OF)
Based on temperature requirements, the medicines storage requirements are classified
as below (Rankin et al, 1997)
Preserving Efficacy of Temp. Sensitive Medicines 16
Store frozen: Vaccines and insulin need to be transported at sub-zero degree
temperature, sometimes stored at -20°C.
Store at 2°-8°: This is normal temperature for the storage of any temperature sensitive
medicines and must be kept in the middle part of the refrigerator.
Keep cool: This term is used when a medicine must be kept at temperature 8°-15°C.
Store at room temperature/ambient temperature: Term ambient temperature is out-
dated because of variations in temperature. When mentioned, it means “room
temperature”. Store at 15°-25°C or up to 30°C, area should be clean, dry and
ventilated.
2.3 Cold Supply Chain
2.3.1 Temperature Control of Raw Material
The manufacturer is responsible for ensuring the stability of manufactured
dosage. Temperature, light, air and humidity are the main stability parameters
specially packaging. Stability testing needs to be conducted on real time temperature
and relative humidity representing storage conditions experienced in the chain of
distribution of different climate zones of different countries. (Desmond, 2005)
Mischler (2002) states that multinationals are defining new conditions of stability
testing for global market. For that they test stability at 50oC & 75% RH. The concept
behind this is to recommend a lower shelf life when exposed to higher ambient
temperatures.
It has been also observed that drugs pack in blister packing gained moisturize at
higher rate when compared to drugs having strips packing (Bajaj, Singla, & Sakhuja,
2012).
Preserving Efficacy of Temp. Sensitive Medicines 17
2.3.2 Packaging & Labeling of Temperature Sensitive Medicine
As discuss earlier that protecting a temperature sensitive medicine from heat
excursion is gaining importance as the number of biopharmaceutical products are
increasing and authorities look for evidence of product stability throughout the chain.
Considering the need for protecting against excessive temperaturs, DHL a well known
logistics company has introduced DHL Medical Express in 2012 to support the
specific transportation needs for temperature sensitive medicines / vaccines from
research centers / manufacturer to final consumer. They have developed a
comprehensive variety of packaging alternatives you can select from. Different box
sizes within each heat variety range allows selection of the most efficient solution
whilst guaranteeing heat variety precision and stability (DHL Express, 2012).
WHO (2009) specifies a storage space declaration on the lable based on finished
product. Where appropriate; specific guidelines should be provided particularly if the
product cannot tolerate cold. There should be an immediate link between the storage
space declaration on the brand and the finished product. An expiry date should be
shown on the package label. Thus temperature sensitive packaging helps to guarantee
that the products are shipped safely and at the precise temperature.
2.3.3 Temperature Control in Transportation & Distribution
Transportation and distribution play one of the most important role in
protecting the integrity of the product (Taylor, 2006). Good distribution practices
have to be followed to prevent entry of counterfeit medcines. The temperature of
storage cabin/container in the transportation of medicine isjust as important as leaving
personal use medicine in the boot of a car. For longer duration transport such as inter-
city distribution refrigerated lorries should be used to prevent exposure to excessive
temperatire (Fudge, 2009)
Preserving Efficacy of Temp. Sensitive Medicines 18
Where special storage space conditions are specified by the manufacturer, these
should be provided, examined and supervised. Temperature controlled storage, first-in
first-out (FIFO) and good warehousing practices help reduce risk involved in
transportation and distribution (Fudge, 2009).
2.4 Problems in Protecting Temperature Sensitive Medicnes in Pakistan
The pharmaceutical supply chain in Pakistan faces many problems. Regulatory
controls are rather lax and corruption is also ripe. As a result, the retailing in
pharmaceutical sector is largely being handled like a grocery store. Anyone can open
a chemists shop. This part of pharmaceutical supply chain is largely to be blamed for
breaking the cool chain. Many chemists do not have refrigerators required to maintain
the medicines at the required temperature. Hours of load shedding sometime
extending to 10-18 hours make the refrigerators useless anyway.
The top 50 pharmaceutical companies control 80% of the market share while the top
100 companies account for 90% of the pharmaceutical business (Khan & Subzwari,
2009). Larger companies have their own distribution network and can protect
medicines until they are delivered to the retail store.
Vaccination campaign by government often funded by donor agencies have the
resources to maintain a cool chain until the medicines are administered but poor
management, lack of training result in failure of vaccination campaigns.
WHO (2009) has identified lack of infrastructure to maintain a cold supply chain as
one of the major problems in failure to immunize children against polio, measles,
MMR and Rubella,claims that one of the biggest problem in Pakistan is the
infrastructure of Cold Chain Logistics. WHO also identifies load shedding, poorly
Preserving Efficacy of Temp. Sensitive Medicines 19
educated staff and mismanagement in protecting the medicines from extreme
temperatures (Suhail, 2012)
2.5 Development of Hypotheses
The literature review above emhasizes the importance of maintaining correct
temperatures to protect the efficacy of pharmaceutical products. The supply chain
begins from procurement of raw materials and that in itself can be blamed for the
problem. Medicines are being imported from several countries and mishandling
during shipment cab reduce the potency of the raw materials. Most larger
pharmaceutical companies have their own laboratories and check the raw materials
before formulations.
Protecting the medicines during storage and formulation requires maintenance of cold
chain as required by the medicine. Transportation within the country can take upto
three days of travel time. As ambient temperature can rise upto 45 0C and the
temperature in the storage compartment can be even highe, protecting medicne in this
stage is as important as during other storage. Product must be transported in
temperature controlled transport and a record of temperature during transport would
be a great help.
The last stage is the actual distribution of the shipment to its destination, in logistics
which is known as the "last mile". Trucks, the prime modes of transportation at this
stage, must meet the requirements necessary to ensure cold chain shipment.
Maintenance of the desired temperature at the Chemist is the key to complete the cold
supply chain. It is also the weakest link,
The literture review has helped in identification of the following hypotheses for this
research.
H1 Ensuring temperature control of active ingredients during shipments is
Preserving Efficacy of Temp. Sensitive Medicines 20
positively related to efficacy of imported medicine
H2 Appropriate temperature control of stored raw material and finished
product is positively related to protecting efficacy of the medicine
H3 Maintaining appropriate temperature cool chain from manufacturing to
delivery to the patients is positively related to protecting efficacy of the
medicine
Preserving Efficacy of Temp. Sensitive Medicines 21
Chapter 3: Research Methods
3.1 Method of Data Collection
The data for this thesis was collected through a questionnaire-based survey.
Even a common person understands the problem of counterfeit drugs, expired
medicine and medicine degradation due to exposure to high temperatures. Everyone
has a say therefore, the survey was limited to professionals in pharmaceutical
handling. The questionnaire-based survey was developed on a 5-point Likert scale in
the following scale:
1- Strongly disagree 2- Disagree 3- Neither agree nor disagree
4- Agree 5-Strongly Agree
3.2 Sampling Technique
Non-probability sampling technique has been used for collecting the data.
Pharmaceutical professionals were identified as potential respondents of the survey.
The survey was completed through personal contacts and also by email.
3.3 Sample Size
A sample size of 100+ professionals was planned for the survey. Many of the
emails and personal contacts were not fruitful and a total of 102 questionnaires could
be collected in the available time.
3.4 Instrument of Data Collection
A Questionnaire-based survey was developed to obtain primary data for testing
the hypotheses. The survey contained close-ended questions through which
respondents could specify their agreement/disagreement level to every statement
Preserving Efficacy of Temp. Sensitive Medicines 22
given. Questionnaire was distributed for data collection by personal contact and by
email.
3.4.1 Validity and reliability Test
The data collected from the survey was fed into SPSS data format and analyzed
for validity and reliability. Table 3.2 shows that the Cronbach's Alpha is 0.789, which
is considered reliable.
Table 3.1: Case Processing Summary
N %
Cases Valid 102 100.0
Excluded a 0 .0
Total 102 100.0
a. List-wise deletion based on all variables in the procedure.
Table 3.2: Reliability Statistics
Cronbach's Alpha N of Items
.789 9
3.5 Research Model Developed
Figure 3.1 presents a conceptual research model
Figure 3.1:
Conceptual Research Model (Self Developed)
Maintenance of Cold SC in procurement Cold SC in Mfg and Storage Cold SC in Retail
Protecting Temp, Sensitive Drugs
Preserving Efficacy of Temp. Sensitive Medicines 23
3.6 Statistical technique
Since we are investigating the relationship between multiple independent
variables, we use a one-Sample t-test. A test value of four is set as it corresponds to
respondents’ agreement with the hypotheses.
Preserving Efficacy of Temp. Sensitive Medicines 24
Chapter 4: Results
4.1 Findings and Interpretation of the results
The data collected from the survey was fed into SPSS 17 data format and
analyzed by one sample t-test. The test value was set at four, which is indicative of
respondent’s agreement with the hypothesis. Table 4.1 presents the one sample
statistics showing the mean for hypothesis is greater than four indicating acceptance
of the hypotheses.
In all 3 hypotheses were used to study the factors affecting efficacy of temperature
sensitive medicines. Primary data from 102 respondents revealed all 3 hypotheses.
Table 4.1:
One sample Statistics
N MeanStd.
Deviation
Std. Error Mean
H1: Ensuring temperature control of active ingredients during shipments is positively related to efficacy of imported medicine
102 3.7353 .95364 .09442
H2: Appropriate temperature control of stored raw material and finished product is positively related to protecting efficacy of the medicine
102 4.4314 .83855 .08303
H3: Maintaining appropriate temperature cool chain from manufacturing to delivery to the patients is is positively related to protecting efficacy of the medicine
102 4.1569 .93072 .09216
Preserving Efficacy of Temp. Sensitive Medicines 25
One sample statistics (Table 4.1) shows a mean value of 3.73 for hypothesis-1 while
hypotheses H2 and H3 have values of 4.43 and 4.15. This shows acceptance of
hypotheses h2 and H3, while for H1 the value is inclined towards acceptance but less
than four.
Table 4.2 shows the result of one-sample test. Here t1 and mean difference are
negative for H1, while for H2 and H3 these values are positive as required. The p-
values (Sig-2) of 0.05 are desired but considering mean values, t-values and mean
difference we can conclude acceptance of hypotheses h2 and H3 and reject hypothesis
H1.
Table 4.2:
One-Sample Test
The mean values in Table 4.1 show that hypotheses H2 and H3 have a mean
exceeding test value 4. These hypotheses can be accepted on the basis of mean value.
Hypothesis H1 has a mean value of less than 4 (Mean= 3.73) and can be marginally
accepted on the mean value basis.
Test Value = 4
95% Confidence Interval of the Difference
t dfSig. (2-
tailed)
Mean
DifferenceLower Upper
H1 -2.803 101 .006 -.26471 -.4520 -.0774
H2 5.195 101 .000 .43137 .2667 .5961
H3 1.702 101 .092 .15686 -.0259 .3397
Preserving Efficacy of Temp. Sensitive Medicines 26
One sample test (Table 4.2) clearly shows the problems in accepting H1. For 101
degree of freedom t should be greater than 1.66 (t-distribution table, 2015) while for
H1 this value is negative. Hypotheses H1 can therefore be rejected.
Hypotheses H2 and H3 with mean values greater than 4 and t> 1.66, these hypotheses
can be accepted.
The reason for rejection of H1 is that any deterioration in purity of raw material can
be adjusted at formulation stage and therefore the respondents did not consider it
having a large impact on the formulated product.
4.2 Hypothesis Assessment Summary
The outcome of one-sample t-test is summarized in Table 4.3.
HypothesisMean
value
T
value
p-
value
Mean
Diff.
Empirical
Conclusion
H1
Ensuring temperature control of active ingredients during shipments is positively related to efficacy of imported medicine
3.73 -2.803 .006 -.2647 Rejected
H2
Appropriate temperature control of stored raw material and finished product is positively related to protecting efficacy of the medicine
4.43 5.195 .000 .43137 Accepted
H3
Maintaining appropriate temperature cool chain from manufacturing to delivery to the patients is is positively related to protecting efficacy of the medicine
4.15 1.702 .092 .15686 Accepted
Preserving Efficacy of Temp. Sensitive Medicines 27
Chapter 5: Discussions, Conclusion, Policy Implications and Future Research
5.1 Discussions
Pakistani health sector has many problems. The government funding for the
health sectors is merely 2.3 % of GDP (Dawn, 2013) compared to 4.2% in India, 4 %
In Sri Lanka and 7.4% in Afghanistan. The quality of healthcare in public sector
hospital is so poor that many people do not want to go to those hospitals and bear the
cost of medical care themselves. In public sector hospitals patients are often asked to
buy expensive medicines themselves. Unfortunately the medicines are often
substandard, counterfeit, expired or have lost their potency due to exposure to
excessive temperature during storage and transportation.
Ordinary people spend their hard-earned savings on buying medicines that has already
deteriorated to be of any therapeutic value. Normal medicines available at chemist
require storage at around 25 0C. The ambient temperature during summer months is
between 40-45 0C. Most of the medicines are left in shelves at ambient temperature
where their potency declines due to exposure to high temperatures. These chemist
stores need to be maintained at 25 0C for protecting the medicine on shelf.
Medicines that require 4-8 0C temperature are stored in refrigerators when available
but a refrigerator is not much help in 10-12 hours of load shedding. Regulatory action
is required to protect the interests of the public and particularly patients. The larger
chemists such as Kausar Medicos, Islamabad Medicos are equipped to maintain
temperatures. The government needs to coordinate management of dispensing
chemists under control of local pharmaceutical association, Pakistan Pharmaceutical
Manufacturing Association (PPMA). The outlets must conform to certain standards,
be equipped with standby power supply, maintain premises temperature at 25 0C for
Preserving Efficacy of Temp. Sensitive Medicines 28
routine shelf storage and refrigerated storage for frozen and 4-8 0C storage of
medicine when required. The value of medicine sold nationwide was estimated at $3.2
billion (Rs 330 billion) in 2014 (PPMA, 2014). These kind of assets need to be
safeguarded well. A reputation of spurious drugs due to mismanagement in transport
and storage, infiltration of counterfeit drugs is not going to help the pharmaceutical
sector. Maintenance of cold chain in transportation, storage and retail is in the interest
of pharmaceutical sector. Professionally managed retail store with support from
government and pharmaceutical sector is in the interest of the sector and the
consumer.
5.2 Conclusion
The research project shows that the pharmaceutical sector and government
need to play their role in protecting the efficacy of medicine. The set-up of modern
chemist shop such as Boots-the Chemist can be set-up in Pakistan. It need not require
major funding from any of the agency or pharmaceutical sector, after all major
supermarkets are operating well-maintained Chemist sections and even offering
discount of typically 10% on the medicines sold.
Government needs to discourage giving licenses to chemists who do not meet a
minimum standard of storing and maintaining environment necessary to protect the
medicine.
5.3 Policy Implications
The research has highlighted the need of involving pharmaceutical sector and
regulatory bodies to ensure that the retail outlets are professionally maintained and
managed. Throughout the developed world Chemist shops are commercially viable
Preserving Efficacy of Temp. Sensitive Medicines 29
even when they are run under strict requirement to protect efficacy of temperature
sensitive medicines.
5.4 Future Research
Financial viability of professionally managed chemist outlets needs to be
determined. In large cities, they are commercially viable. In smaller towns and
villages these shops may require pharmaceutical sector support. For temperatures
sensitive products requiring low temperature storage, courier service can deliver the
medicine in ice packs etc.
Preserving Efficacy of Temp. Sensitive Medicines 30
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Bhadra, D., Gupta, G., Bhadra, S., R. B. Umamaheshwari, R. B. & Jain, N, (2004), Multicomposite ultrathin capsules for sustained ocular delivery of ciprofloxacin hydrochloride. Journal of Pharmacy & Pharmaceutical Sciences, Vol. 7, No. 2, 241, available online, retrieved 4 June 2015, https://www.ualberta.ca/~csps/JPPS7(2)/N.Jain/ciprofloxacin.htm
Bishra, R. H. (2006). Cold Chain Management - An Essential Component of the Global Pharmaceutical Supply Chain. American Pharmaceutical Review .
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Preserving Efficacy of Temp. Sensitive Medicines 31
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Preserving Efficacy of Temp. Sensitive Medicines 32
APPENDIX
QUESTIONNAIRE
As a part of my MBA course, I am working on a research project on “Preserving the Efficacy of Temperature Sensitive Medicine-Logistics Management in Pharmaceutical Supply Chain”. The information provided will be exclusively used for the research project. It would be very much appreciated if you would spend a few minutes of your precious time to answer the questions given below. Thank you for your cooperation.
Name: Gender
Male Female
Organization: Designation:
Years in
Organization:
Less than 1 1 to 5 6 to 10 More than 10
Your involvement in Supply Chain
activities
None Procurement Production Marketing
Transportation Retail Administering (health staff)
Other (Please Specify); ___________________
Contact Info. (Phone, Email,)
Visiting card if available would be
very much appreciated)
Phone:
Email:
Visiting Card Attached Not available
Please indicate your agreement/disagreement with the following statements using the scale
given below:
Strongly Disagree Disagree Neutral Agree Strongly
Agree
1 2 3 4 5
Preserving Efficacy of Temp. Sensitive Medicines 33
Questionnaire (Continued)
S. No
Stro
ngly
D
isag
ree
Dis
agre
e
Neu
tral
Agr
ee
Stro
ngly
A
gree
1.1.
Pharmaceutical active ingredients are mostly imported either as concentrate for local formulation or as ready to sell product.
1О
2О
3О
4О
5О
2.2
Storage temperature during shipping must be specified and if necessary monitored.
1О
2О
3О
4О
5О
3.H
Storage of temperature sensitive medicine at raw material and finished product stage must be in appropriate temperature controlled stores.
1О
2О
3О
4О
5О
4. Quality & efficacy of medicine must be determined if it is suspected that the cold chain has been broken.
1О
2О
3О
4О
5О
5.H Temperature maintenance and control during production
is necessary to protect efficacy of medicine.1О
2О
3О
4О
5О
6.H
Refrigerated vehicles, ice packs to maintain temperature and well-insulated cool boxes are required to maintain desired temperature during transportation.
1О
2О
3О
4О
5О
7. Cases of polio in children who received polio vaccine is ample evidence of failure to maintain cool chain in medicine distribution system.
1О
2О
3О
4О
5О
8.H
Failure to maintain desired conditions of storage environment may make the medicine unfit for use or reduce its efficacy.
1О
2О
3О
4О
5О
9.H
Effective logistics management in pharmaceutical supply chain is crucial to the reputation of pharmaceutical company and efficacy of its medicines
1О
2О
3О
4О
5О
Thank you for your help
Preserving Efficacy of Temp. Sensitive Medicines 34
SPSS Output
T-Test
One-Sample Statistics
N Mean Std. Deviation Std. Error Mean
H1 102 3.7353 .95364 .09442
H2 102 4.4314 .83855 .08303
H3 102 4.1569 .93072 .09216
One-Sample Test
Test Value = 4
95% Confidence Interval of the
Difference
t Lower Upper
Mean
Difference Lower Upper
H1 -2.803 -.4520 -.0774 -.26471 -.4520 -.0774
H2 5.195 .2667 .5961 .43137 .2667 .5961
H3 1.702 -.0259 .3397 .15686 -.0259 .3397
Preserving Efficacy of Temp. Sensitive Medicines 35
Reliability
Scale: ALL VARIABLES
Case Processing Summary
N %
Cases Valid 102 100.0
Excluded 0 .0
Total 102 100.0
a. List wise deletion based on all variables in the
procedure.
Reliability Statistics
Cronbach's Alpha N of Items
.789 9