t2 final

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.


ii ii


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.


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


iv


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


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


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


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


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.


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.


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


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:


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)


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).


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)


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


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


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


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


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


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.


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


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


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


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


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


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.


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T- distribution Table (2015), Statistical Table, Also available online, retrieved 4 June 2015, https://www.easycalculation.com/statistics/t-distribution-critical-value-table.php

Taylor J. (2003) Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products, Pharm J., 28 (267): 128- 131

Taylor, J. (2006). Pharmaceutical Journal .

WHO. (2009). WHO Technical Report Series. Stability testing of active pharmaceutical ingredients and finished pharmaceutical products .


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


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


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


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

t2 final

Documents

karachi karachi

product manufacturing

comprehensive research

hospitals of karachi

vital role

pharmaceutical supply

thesis supervisor

significant role