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EVALUATION OF THE DRUGS RECALL SYSTEM IN SAUDI ARABIA: GUIDANCE AND PROCEDURES

OMNIYAH ALHARTHI

SCHOOL OF CHEMICAL AND PHARMACEUTICAL SCIENCES

DIT KEVIN ST.

APRIL 2017

DISSERTATION SUBMITTED IN PARTIAL FULFILMENT OF

EXAMINATION REQUIREMENTS LEADING TO THE AWARD

OF

MSc in Pharmaceutical Quality Assurance and Biotechnology (DT233)

(DUBLIN INSTITUTE OF TECHNOLOGY)

Supervisors

Dr Elaine Harris

 Dr Ibrahim Aljuffali

 

Declaration

I certify that this dissertation is entirely my own work and has not been taken from the work of others save and to the extent that such work has been cited and acknowledged within the text of my work.

This dissertation has not been submitted in whole or in part for an award in any other institute or university.

The institute has permission to keep, to lend or to copy this dissertation in whole or in part, on condition that any such use of the material of the dissertation is duly acknowledged.

Signed:

Date :

Acknowledgements

First of all, I would like to give special thanks for my Family, lovely husband, and my friends who continuously supported and encouraged me to do my best at this long journey.

Thanks to my mom and dad who always believed in me and motivated me to be the best and to continuously succeed in any step I pass in. Thanks to my brothers and sisters for showing their big support.

Big thanks also to my supervisors for giving their support and perfect guidance to complete this work as it is illustrated now.

And above all, thank you God for guiding me and standing by my side through this wonderful journey.

'

Abstract

This study attempts to evaluate the drugs recall system in Saudi Arabia through reviewing its guidance and procedures formulated by the Saudi Food and Drug Authority (SFDA), as well as evaluate the effect of drug prescriptions on the effectiveness of the drugs recall in Saudi Arabia, and finally, define the main obstacles faced by the SFDA employees in applying the drugs recall system. In order to achieve the objectives of the study, mixed methods were implemented by using both quantitative and qualitative methods. The qualitative research was implemented by gathering background information about the study from appropriate literature, and reviewing the guidance and procedures formulated by the SFDA. The data for quantitative analysis was obtained from two questionnaires that were distributed to a sample of SFDA employees and pharmacists from public hospitals and medical stores in Makkah, Saudi Arabia. The first questionnaire is titled as 'Registering drugs prescriptions' which aims directly to investigate the effect of the drugs prescriptions on the ability of the drugs recall in Saudi Arabia which is one of the main study aims. This questionnaire sample consisted of 63 responses from pharmacists in public hospitals and medical supply from Makkah in Saudi Arabia. The second questionnaire was directed to a sample of 103 SFDA employees to ascertain the main obstacles encountered by them during the drug recall process in Saudi Arabia. The study results revealed that there is a positive effect of using and registering drug prescriptions on the ability of the drugs recall in Saudi Arabia. The present study also evaluated the drug recall system in Saudi Arabia through reviewing its guidance and procedures formulated by Saudi Food and Drug Authority, and found the system to be in accordance with the leading international drug recall systems. However, the questionnaire results revealed that the SFDA employees faced several challenges in implementing the drug recall process effectively. Moreover, the responses also revealed that there is a lack of sufficient information about the drug recall process among the pharmacists. Through addressing these issues, the drug recall process in Saudi Arabia can be improved further.

Glossary

FDA:             Food and Drug Authority (US).

SFDA:           Saudi Food and Drug Authority.   

API:             Active Pharmaceutical Ingredients.

TGA:           Australian Government Department of Health.

EMA:           European Medicines Agency.

PMS:            Pharmaceutical Monitoring System.

NDA:           New Drug Application.  

SRA:           Stringent Regulatory Authority.

SDR:           Saudi Drug Registration System.

IBRCS:       Importing, Batch-Release and Clearance System.

MHRA:      Medicines and Healthcare products Regulatory Agency.

DSCHP:     Drugs Supply Chain Process.

CMS:         Central Medical Store.

IND:          Investigational New Drug.

Table of Contents

DECLARATION  1

ACKNOWLEDGEMENTS  2

ABSTRACT  3

GLOSSARY  4

TABLE OF CONTENTS  5

LIST OF TABLES  8

LIST OF FIGURES  9

1      CHAPTER ONE: INTRODUCTION  10

1.1    Background and context of this study  10

1.2 Types of Recalls 11

1.3 Reasons for drug recalls 12

1.4 Research Questions 16

1.5 Research Hypothesis 17

1.6 Research aims and objectives 17

1.7 Dissertation structure 18

2 CHAPTER TWO: LITERATURE REVIEW 19

2.1 Introduction 19

2.2 Drug registration 19

2.3 Drug registration in Other Countries 20

2.4 Drugs registration at Saudi Food Drug Authority (SFDA) 23

2.5 The main guidance and procedures of the drug recall system in KSA 25

2.5.1 Saudi Food and Drugs Authority (background information) 25

2.5.2 Drug recall procedure in SFDA 27

2.5.3 Recall procedure 30

2.5.4 Laboratory testing procedure 32

2.6 Comparison of recall procedures in US, UK, and KSA 33

3 CHAPTER THREE: METHODOLOGY 36

3.1 Introduction 36

3.2 Research strategy 36

3.3 Research approach 36

3.4 Data sources 38

3.5 Data collection techniques 39

3.6 Population and sampling 41

3.7 Ethical Considerations 41

3.8 Presentation and analysis of data 42

3.9 Validity and reliability 42

3.10 Conclusion 44

4 CHAPTER FOUR: RESULTS 45

4.1 Introduction 45

4.2 Respondents demographic profile 46

4.2.1 Questionnaire 1: Pharmacists 46

4.2.2 Questionnaire 2: SFDA Employees 53

4.3 Findings related to Pharmacists practice 57

4.4 Findings related to drug prescriptions and drug recalls 59

4.5 Findings related to drug recall challenges 63

4.6 Summary 65

5 CHAPTER FIVE:  DISCUSSIONS AND RECOMMENDATIONS 66

5.1 Introduction 66

5.2 Results Summary 66

5.3 Discussion 68

5.4 Evaluation of the drugs recalls system 70

5.5 Recommendations 73

5.6 Suggestions for further research 74

5.7 Limitations 74

REFERENCES 76

APPENDIX 1: SURVEY QUESTIONNAIRE 1 81

APPENDIX 2: SURVEY QUESTIONNAIRE 2 86

List of Tables

Table 2.1: Number of batches recalled in the last three years 29

Table 2.2: Drug recall procedures in different countries 34

Table 3.1: Cronbach alpha values 43

Table :4.1 Pharmacists Gender 46

Table  4.2: Pharmacists Age 47

Table 4.3: Pharmacists qualifications 48

Table  4.4: Pharmacists experience 49

Table 4.5: Pharmacists work place 50

Table 4.6: Pharmacists usage of computer at their work 52

Table 4.7: SFDA employees age 53

Table 4.8: SFDA employees gender 54

Table 4.9: SFDA employees' educational level 55

Table 4.10: SFDA employees' work experience 56

Table 4.11: Means and standard deviation of responses for 'Pharmacists practice' related questions and total means (n=63) 57

Table 4.12: Results of One-Sample t-Test 58

Table 4.13: Frequencies and percentages of the surveyed Pharmacists' responses on registering drug prescriptions 59

Table 4.14: Mean and standard deviation of responses for 'recall challenges' related questions and total mean (n=103) 63

Table 4.15: Results of the One Sample T-Test 64

List of Figures

Figure 1.1: Recall depth/level descriptions (Lehman, 2010) 12

Figure 1.2: Recall category description (Lehman, 2010) 12

Figure 1.3: Drug recalled due to the presence of mould. 13

Figure 1.4: Drug recalled due to the presence of contaminant 13

Figure 1.5: Counterfeit drugs recalled (o is original and f is fake) 14

Figure 2.1: Flow chart of the submission process (SFDA, 2014). 25

Figure 4.1: Gender of Pharmacists 47

Figure 4.2: Age of Pharmacists 48

Figure 4.3: Qualifications of Pharmacists 49

Figure 4.4: Number of years of experience for the Pharmacists 50

Figure 4.5: The place of work of Pharmacists 51

Figure 4.6: Computer usage at work for Pharmacists 52

Figure 4.7: Age of SFDA employees 53

Figure 4.8: Gender of SFDA employees 54

Figure 4.9: Educational level of SFDA employees 55

Figure 4.10: Number of years of experience of SFDA employees 56

1 Chapter One: Introduction

1.1 Background and context of this study

Pharmaceutical companies seek to produce safe and effective drugs for various diseases with maximum potency and minimal side effects. The main goal for these companies is to manufacture drugs that enhance human life in the safest way possible (Merck, 2008). In order to ensure that the safest drugs possible are produced, most drug candidates proceed through three or four stages of human clinical trials. Stage I is performed to test the toxicity of the drugs while stages II, III and IV are intended to test the drugs' potency and effectiveness by running studies on an expanding number of patients (Food and Drug Administration (FDA), 2002). During this testing phase, the pharmaceutical companies are expected to set up an Institutional Audit Board (IRB) and a Data and Safety Monitoring Board (DSMB) to guarantee the safety of the patients, maintain a strategic distance from their products, and eliminate any preventable hazards (Couturier, 2010).

Once the drugs have passed through the testing and approval stages, they hit the market and are accessed by patients. However, there may be cases of some defective drugs or other product issues which may have been overlooked during the manufacturing or testing stages. When such products are consumed by patients, they may pose serious health risks. Thus, a process needs to be in place to withdraw a drug that has already entered the market. This process is called the drug recall.

In recent years, there has been an increase in the number of drug recalls throughout the world (Levine and Cox, 2010). The FDA registered that 1,742 drugs were recalled in 2009, which is a significant increase in comparison to the 426 drugs recalled in 2008 (Levine and Cox, 2010; Kavilanz, 2010). This increase in the number of recalled drugs likely indicates the increased vigilance by the authorities in response to the ever growing variety of drugs entering the market for various conditions.

Drug recalls are an appropriate and necessary process for removing products from market which violate the laws laid down by the regulatory authorities of different countries, for example, the Food and Drug Administration (FDA) in the USA. A recall may be initiated by manufacturers in order to fulfil their responsibility to protect the public health from defective products or products that present risk to consumers. Firms also initiate a recall following notification of a problem by the FDA (Food and Drug Administration) or a relevant state agency (FDA, 2009).

1.2 Types of Recalls

First of all, we should differentiate between market withdrawals and drug recalls.  Although both processes include a removal or correction of a product, a recall is a removal due to problems that are in violation of the law and therefore subject to legal action by FDA. Whereas, market withdrawal is a removal in response to a minor violation that would not typically be subject to legal action by the FDA (U.S. FDA, 2016a).

Recalls may be initiated by FDA order under statutory authority or by an individual manufacturer or distributor by the FDA request (U.S. FDA, 2016b). The majority of drug recalls are voluntary by the firm, but if the FDA recognizes a potential issue with a specific product, then a formal request will be sent to the firm. However, when a firm issues a voluntary recall, it will assign the depth of recall, which indicates the level in the distribution chain to which a recall is extended based on the hazard associated with use of the affected product and the extent of the product distribution. Figure 1.1 describes the different levels of recall. Moreover, the drug recalls are classified into different types depending on their health risks, as shown in Figure 1.2 (Lehman, 2010).

Figure 1.1: Recall depth/level descriptions (Lehman, 2010)

Figure 1.2: Recall category description (Lehman, 2010)

1.3 Reasons for drug recalls

The number of drug recalls have been increasing over the last few years, generally due to problems occurring during the manufacturing or distribution process, including raw material impurities or contaminants, stability or sterility issues, sub- or super-potent amounts of active ingredients in final products, labelling and packaging errors, bad storage, and side effects (Kavilanz, 2010). Figures 1.3 to 1.5 show samples of drugs that have been recalled for different reasons:

Figure 1.3: Drug recalled due to the presence of mould (the researcher, 2017).

Figure 1.4: Drug recalled due to the presence of contaminant (the researcher, 2017)

Figure 1.5: Counterfeit drugs recalled (o is original and f is fake) (the researcher, 2017)

According to Matos (2010), the pressure of generic companies to manufacture the first FDA-approved generic for brand name products coming off patent and outsourcing are producing significant issues in quality assurance. An additional reason for the increased number of recalls is the greater FDA scrutiny of manufacturers and facilities following high-profile recalls involving firms such as Johnson and Johnson's, where the publicity surrounding these recalls may have increased the vigilance of patients and healthcare providers in reporting problems about products and reporting complaints to manufacturers and the FDA (Matos, 2010).

Although there is a procedure set up for both recalling firms and the FDA, there are still issues with drug recalls at national and international levels. There is concern about the timeline when an individual firm issues a recall once it becomes aware of problems with an item. (U.S. FDA, 2001).

When a pharmaceutical organization becomes aware of a potential health danger, the organization will attempt to examine that hazard and direct new studies to test the speculation, regardless of the fact that it is costly for the pharmaceutical firm. As indicated by Title 21, Code of Federal Regulations area 314.80, medical manufacturers must commit to quickly assessing all unfavourable drugs and report those cases to the FDA within 15 days (FDA, 2009). The side effect cases form roughly 90 percent of the reports sent to the FDA (Woodcock, 2000). Also, if new issues are found during studies. it is expected that they will give this data to the FDA, regardless of the fact that the outcomes are negative (Couturier, 2010).

Consequently, there must be basic standards for the drug identification process and guidance of the drugs manufacturing in general, and for recall drugs in particular in the healthcare field, in order to make the drugs supply chain process (DSCHP) in Saudi Arabia, more secure and also more productive and accurate. Moreover, the Drug Sector in Saudi Food and Drug Authority (SFDA) trusts that the basic standards for drugs identification process and guidance from the manufacturer to the patient are vitally important for drugs safety (Kingdom of Saudi Arabia SFDA, 2013).

Furthermore, the SFDA was built up under the Council of Ministers determination no (1) dated 07/01/1424 H, as an autonomous corporate body that specifically reports to the Premier. The goal of SFDA is to guarantee health, sustenance and drugs for humans and animals, and safety of organic and synthetic substances as well as electronic items. The fundamental vision of SFDA is to be the main local administrative power for all food, drugs and medicinal devices in order to ensure the progression of health in Saudi Arabia. In this manner, the mission of SFDA is to guarantee the security of food; the health, quality and viability of drugs; and the quality and adequacy of restorative devices, by creating and upholding a suitable administrative framework. The fundamental goals of the SFDA foundation are to (ICRM, 2014):

1. Regulate, manage, and control sustenance, sedation and medical devices

2. Set required standard details thereof, whether they are transported in or privately produced

3. Control as well as test the products in the research facilities of SFDA or other organizations

4. Take charge of customer awareness on all matters related to food, drugs and medical tools, and other related items and supplies.

Generally, in Saudi Arabia, Medical Supply is considered as the Central Medical Store (CMS) at National Level for the government supply system (SFDA and WHO, 2012). There are approximately 20 medical suppliers and 200 pharmaceutical companies (mostly retailers) in Saudi Arabia registered with the Ministry of Health (MOH). The drug market consists largely of  European providers. There are more than forty operators in Saudi Arabia that import medicines from worldwide pharmaceutical organizations (UBIC-consulting, 2011).

Thus far, a  brief description of the drug recall system in Saudi Arabia has been presented. Now, it is important to assess in depth how this drug recall system works in Saudi Arabia, and identify its strengths and weaknesses. Therefore, this study attempts to evaluate the drugs recall system in Saudi Arabia through reviewing its guidance and procedures.

1.4 Research Questions

As the main concern of this study is to evaluate the drugs recall system in Saudi Arabia through reviewing its guidance and procedures, the next questions it seeks to resolve are:

What is the evaluation of the drugs recall system in Saudi Arabia in terms of its guidance and procedures?

This major question will be addressed by answering these specific questions:

' What are the main guidelines and procedures of the drug recall system in Saudi Arabia?

' To what extent does the recall system follow the quality control standards in Saudi Arabia?

' How many drugs were recalled by the SFDA during the time period 2015 to 2017?

' What are the main strengths, weaknesses, and opportunities that can be found in the drugs recall system in Saudi Arabia?

' What is the effect of drug prescriptions on the drugs recall process in Saudi Arabia?

' What are the main obstacles faced by the SFDA employees in applying the drugs recall system?

1.5 Research Hypothesis

The below two hypotheses are proposed in order to respond to the questions raised:

' H1: The recall system in Saudi Arabia follows the quality control standards to a large degree.

' H2: There is a positive effect of the drug prescriptions on the drug recall system in Saudi Arabia.

1.6 Research aims and objectives

The main aim of this study is to evaluate the drug recall system in Saudi Arabia through reviewing the guidance and procedures formulated by Saudi Food and Drug Authority.

The following study objectives can be derived from this aim:

' Reviewing the main guidance and procedures of the drug recall system in Saudi Arabia and determining to what extent this system follows the quality control standards.

' Determining the number of drugs that were recalled by SFDA between 2015 to 2017.

' Assessing the strengths, weaknesses, and opportunities for improving the drug recall system in Saudi Arabia.

' Evaluating the effect of drug prescriptions on the effectiveness of the drug recall system in Saudi Arabia.   

' Identifying the main obstacles faced by the SFDA employees in applying the drug recall system, such as the recall process for dispensing drugs to patients, and the speed of the drug recall process in Saudi Arabia.

' Providing suitable recommendations to the SFDA for further improving the drug recall system in Saudi Arabia.

1.7 Dissertation structure

This study has been divided into five main chapters. The first chapter is the introduction chapter that includes a general background and presents the research questions, aim and objectives. The second chapter contains a review of literature that is relevant to the study topic. Chapter three describes the detailed research methodology used in this work. Next, the results are presented in chapter four, and the final chapter includes a discussion of the study results and recommendations.

2 Chapter Two: Literature Review

2.1 Introduction

The intake of harmful, poor quality and ineffective drugs may lead to failure treatment, exacerbation of disease, and even death in some cases. It also undermines confidence in the health systems, health professionals and pharmaceutical producers and distributors. Thus, firms must keep testing their drugs to enhance the human life in the safest way.

Drug recall is a procedure that involves removing a pharmaceutical product from the distribution and storage chain, due to many reasons such as defects in the product. However, the recall might be initiated by the manufacturer, wholesaler, importer, distributor or Food & Drug Authority (SFDA guideline, 2014). This chapter will give background information about the main guidance and procedure of the drug recall system in KSA compared to the existing drug recall systems in USA and UK. First, the drug registration process will be discussed.

2.2 Drug registration

Drugs have become an important part of public health; governments are willing  to spend more money on healthcare systems in order to restore health, prevent disease, and restore health. However, to ensure that drugs are prescribed with safe and effective quality standards, drugs should be properly regulated throughout development, production, importation, and distribution stages. (Chan, 2013).

Drug regulation's primary aim is to protect the public health in addition to public allow access of  essential medicines, which is a fundamental human right according to the World Health Organisation (WHO). Thus, it is important that drugs should be approved with high standards in efficacy, safety, and quality, in timely manner. The rush to approve new drug could lead to serious injuries, diseases, or even deaths due to the consumption of poor, ineffective quality, and harmful medicines if this speed results in a decrease in standards. While, the slow approval process and the inaccessibility of appropriate medications will make patients suffer and increase the morality rate. A key responsibility of the government of each country is to protect their citizens and to establish strong health authorities ('Competent Bodies') in order to ensure that medicines are regulated effectively (Lembit and Budiono, 2008).

The activities of medicinal regulators may vary between countries in the scope of criteria and the way their regulations are implemented. However, the health authorities which govern drug registration in all these countries are responsible for assessment on safety, quality, and efficacy of each product, and safety of marketed medicines, issuing marketing authorization to new medicinal products, the authorization of the manufacturing import, export, and distribution of medicine licence, in addition to controlling  and monitoring the quality of the marketed products.

 Furthermore, the health authority play an important role on the post-marketing pharmacovigilance system as it is important to trace the safety, efficacy, and quality of all approved drugs and to track the safety profile in a much bigger population size (WHO, 2003).

2.3 Drug registration in Other Countries

In this section drug registration in two main regulatory agencies in the world will be summarized; drug registration in United States and in Europe Union countries, in order to compare regulations in these countries with regulation in KSA.

' Drug registration in United States:

Many researchers consider that the United States has the world's most stringent standards for new drugs approval (Rick, 2015), so it is worth considering how the drug registration system works in the US. There are three main types of applications for new drug registration:

Investigational New Drug (IND) Application: is an application filed to the FDA to start clinical trials in humans. When the reports of preclinical trials show that the drug is safe, then a meeting can be arranged between the sponsor firm and the FDA in order to discuss the following points:

- The design of animal research, which is required to lend support to the clinical studies.

- The chemistry, manufacturing, and quality control of the investigational drug.

- The intended protocol for conducting the clinical trial (Kashyap et al., 2013).

Such a meeting will help the sponsor firm to gather data, organise animal research, and design the clinical protocol according to the FDA's suggestions.

New Drug Application (NDA): Once the clinical studies show that a new drug is effective, safe, and will not cause any risks to patients, then the manufacturer files a new drug application to sell the drug in the United States (Rick, 2015).

Abbreviated new drug application (ANDA): This application is made for approval of generic drugs. Generic drug manufacturers must demonstrate that their product is the same as the original approved one, but they are not required to reproduce the clinical studies that were done with the original drug (Berry and Martin, 2008).  

' Drug registration in Europe:

Before drug is approved there are two regulatory steps to go through in order to be marketed in the European Union: clinical trial application and marketing authorization application.  The clinical trial applications are approved at the member state level (27 member states), while marketing authorization applications are approved at member state or centralised levels  (Berry, Martin, 2008).

Centralised procedure: this procedure allows applicants to obtain a marketing authorisation that is valid among the European Union (Rick, 2015).

- Results in a single authorization valid in European Union, Iceland, Norway, and Liechtenstein.

- Evaluating application by an assigned rapporteur.

- EMA (European Medicines Agency) opinion issued within 210 days, and then submitted to European Commission for final approval.

This process is required for:

' Medicines officially designed 'orphan medicines'.

' Medicines which are derived from any biotechnology process like genetic engineering.

' Medicines which are intended for the treatment of HIV/Aids, Cancer, diabetes, neurodegenerative disorders or autoimmune diseases and other immune dysfunctions.  

Mutual recognition procedure: this process allows applicants to obtain a marketing authorization in the member states (concern members) other than other member states where the drug is previously approved (Kashyap et al., 2013).

- Applicant submits identical file with the required information to all EU member states in which it wants authorization.

- As soon as one member state decides to evaluate the medical product, it notifies this decision to other member states.

- The member state that decides to evaluate the product issues a report to other states including the findings.

- Generic industry is the main user of this type of drug approval procedure.

- This process may consume a time period of 390 days (Berry, Martin, 2008).

Decentralized procedure: in this procedure companies may apply for authorization simultaneously in more than one country in EU, for products that have not yet been authorized in any EU country, particularly those that do not fall within the centralized procedure's essential drugs list (Kashyap et al., 2013).  

2.4 Drugs registration at Saudi Food Drug Authority (SFDA)

The Drug Sector at Saudi Food Drug Authority (SFDA) sets the rules for different types of drugs registration. Such rules are important in order to help the applicants to decide whether to submit their drug applications or not. However, if the following rules met, the drug application submits will be accepted:

1. New drug and biological (either registered in Stringent Regulatory Authority SRA or not).

2. Bio-similar drug only if it manufactured locally.

3. Bio-similar drug if registered in an SRA.

4. Generic drug that is equivalent to the registered innovator in an SRA.

5. Combination products (2 or more API), there are two cases:

- The application is considered generic, if the API's are registered in KSA as single drugs with the same dosage form, strength, and therapeutic indication.

- The application is considered new drug, if one or more of the API's are not registered in KSA.

Moreover, it should be noted that if the generic drugs are not equivalent to the innovated product in the strength, and the API (Active Pharmaceutical Ingredients) is registered in KSA, the drugs considered generic. On the other hand, if the generic drugs are not equivalent to the innovated product in the dosage form, and the API is registered in KSA, they considered new drug (SFDA, 2014).

New drug submission process

The new drug submission process in the SFDA consists of three main steps, as the following:

- Online submission of the application form.

- The product file delivered in person.

- And drugs samples.

Where, the procedure is as the following:

' Applicant shall go to the Saudi Drug Registration System (SDR) website: http://sdr.sfda.gov.sa/.  

' The applicant then should have a user ID and a password and login to apply.

' Then, the applicant need to complete the appropriate application form.

' The applicant has to pay the submission fee in order to submit the application form and schedule an appointment to deliver both hard and soft copy of the product file.

' At the appointment, the applicant will deliver the product file along with the samples.

Finally, the regulatory affairs pharmacist will validate the following:

- The product file (soft and hard copy).

- The application form.

- The samples.

If all of the above are valid, then the applicant will receive an acknowledgement letter and the drug application will enter the queue. But, if some of the above are missing or not satisfactory, the applicant will receive an acknowledgement letter stating the deficiencies. The applicant will have a period of 90 days to complete the requirements and the drug application will not be queued. Then, when the information is completed and completion appointment is requested by email and step 6 will be repeated again (figure 2.1) shows the submission process) (SFDA, 2014).

Figure 2.1: Flow chart of the submission process (SFDA, 2014).

2.5 The main guidance and procedures of the drug recall system in KSA

When pharmaceutical products are suspected of being harmful to users due to a defect in quality, efficacy, or safety, they may be subjected to a recall. In Saudi Arabia the Saudi Food and Drugs Authority (SFDA) is the authority that responsible for regulations of drugs and medical devices which also responsible for drugs recall.

2.5.1 Saudi Food and Drugs Authority (background information)

Saudi Food and Drugs Authority (SFDA) was established by the Council of Ministers decision No. 1 of 7/1/1424 A.H., as an independent body directly linked to the president of council of ministers. The SFDA has several procedural, executive and supervisory tasks in order to ensure the safety of food and drugs for humans and animals and ensure the safety of chemical, biological and electronic products that affect human health.

' The main objective of the establishment of this body is to supervise and control food, medicine, diagnostic and medical devices and products, it is also responsible to test these products in their laboratories or laboratories belonging to other parties. In addition to educate the consumer in all matters relating to food, medicine, medical devices and all related products.

' The vision of SFDA is to be the leading regional drug regulatory authority for pharmaceuticals and cosmetic products, in addition to provide professional services that contribute to the protection and advancement of public health in KSA.

' The mission of SFDA is to protect public health by ensuring quality, efficacy, safety, and accessibility of human and veterinary drugs, biological products, and safety of cosmetics, by managing a national regulatory system which is in line with the international best practice. Also, the agency provides accurate and scientific-based information to the public and healthcare professionals (SFDA, 2015).

The tasks entrusted to the SFDA can be summarised as the following:

- Licensing the processes of manufacturing, importing, exporting, distribution, and promotion and advertising of medicines.

- Assess the pharmaceutical products effectiveness, safety, and quality, in addition to licensing the marketing of these products.

- Inspection of factories and medicines stores.

- Control the traded drugs and check their quality, effectiveness, and safety.

- Monitor and control the adverse effects that may result from taking medications.

- Verification of the safety of cosmetics.

- Building an effective relationship with the international regulatory and scientific societies.

- Enhance the community's drug awareness.

- Setting rules and regulations which are needed to manage the drugs market.

- Follow-up drugs after marketing and prevent any illegal marketing mediums.

- Deliver health messages and documented information about drugs for professionals and the public (SFDA, 2016).

Moreover, according to the SFDA regulations, all the pharmacists in Saudi Arabia must be registered and have a valid license to dispense medications  (SFDA, 2016). Only Saudi Arabia nationals are allowed to own a pharmacy and have a license for operating the pharmacy (SFDA, 2016). The Saudi Commission for Health Specialties provides licences to the pharmacists after they take and pass a Prometric test (SFDA, 2016).

2.5.2 Drug recall procedure in SFDA  

The Saudi Food and Drug Administration ask the agents or suppliers to recall a product if the product has defect in quality. Where the defect can be discovered due to the following procedures:

- The permanent follow-up to global regulators issued warnings or recalling pertaining to pharmaceuticals.

- The follow-up quality products programs marketed by the SFDA by recalling samples from warehouses medications to make sure they conform to the specifications.

- Complaints about the quality of products from citizens, which are then verified by the SFDA.

After the issuance of the recall decision, the SFDA continues to process with the agent according to deadline, and the SFDA inspectors verify the absence of the recalled product in health authorities and check the status of the recalled product. After the end of the recalled process, a date set in coordination with the authority inspector in order to destruct the product. However, drugs are not recalled until the authority verifies the non-conformity of the specifications (SFDA, 2016).

There are several points that should be taken into account in the drug recall system, summarised in SFDA guidelines (2014) as the following:

- There should be a system, including a written procedure in order to recall pharmaceutical products that are known or suspected to be defective effectively. Moreover, this procedure should be regularly checked and updated when it is necessary.  

- The effectiveness of the recall arrangements should be regularly evaluated, and all recalled drugs should be stored in a secure and segregated area.

- The original manufacturer should be informed in the event of a recall. Both original manufacturer and the relevant health authority should be informed, if the recall is due to difficulties in distinguishing between the original product and the counterfeited product.

- Recalled pharmaceutical products should be segregated during transit and clearly labelled as recalled products.

- All competent authorities and customers of all countries to which a given drug have been distributed should be informed.

- During storage and transit of recalled drugs, a particular storage conditions applicable to these products should be maintained

- All records which contain sufficient information on the products should be available to the person(s) responsible for recalls.

- The recall process's progress should be recorded and a final report issued..

- If necessary, an emergency recall procedures should be implemented.

The following Table 2.1 shows the number of batches and drug quantities that have been recalled in the last three years. The next section describes in detail how the SFDA receives reports on drug quality and how it handles these reports.

Table 2.1: Number of batches recalled in the last three years

No. Year Number of recalled batches Quantities that the company was obliged to recall

1 2014 61 3007721

2 2015 5 436388

3 2016 12 9815054

Drugs quality reports are received in one of the following methods:

- Fill electronic forms that exist in the SFDA site or fill the form by hand and send it back to the SFDA address or e-mail.

- Reports received by official letter from government agencies or health facilities.

- Major health world organization and bodies are monitored weekly (the US food and Drug Administration FDA, Health Canada, the Australian Government department of Health TGA, European Medical Agency EMA) then SFDA deal with what was published in the reports of these bodies about products that not matching the specifications.

- Letter or e-mail from product agent or scientific office of the company stating the existence of a defect in the product.

- By contacting the SFDA's unified contact centre.

After receiving the report, the SFDA verifies it through the following:

- Receive the report and enter all available information in the drug industry shared file database, in addition to fill verification of work procedure forms and give the report an identification number in the same business day.

- Check whether the product registered in the existing drugs database through the SFDA website.

- Verify the product if it allowed in KSA or not through the Importing, Batch-Release and Clearance System (IBRCS) program. Which is an electronic system that issue clearance and importing permissions of pharmaceutical shipments and notify the SFDA about any batch released by the local manufacturers to the market.

- If the product is registered or not registered but allowed, the SFDA communicate with the informer to take additional information regarding the report in terms of the number of defected samples and storage conditions if needed.

- In case the product is not registered and not allowed then the report closed and the informer notified that the SFDA cannot guarantee the safety of drugs that not registered or allowed (SFDA, 1438 A.H.).

2.5.3 Recall procedure

In the case where the report is received by letter or e-mail from the product's agent or scientific office of the company, the defective product is evaluated and then the drug batch is recalled when summoned. Samples ordered from the place of complaint by telephone or e-mail depending on the quantities required for analysis. Then, a postal services form is filled out, through Bwabaty-general services- mail section- postal services request form, then the form sent to the public relations department at the SFDA. Upon the arrival of the sample, the transport conditions are verified, and then entered into the "LIMS" program (laboratory Information Management System). The report form attached with the application and the product sample sends to medicine sector laboratory.

The company then shall be addressed according to the received report, and another samples from the same batch required in the following cases:

- If the results of the required samples analysis do not match the specifications.

- If reports on the same product repeated

- If the sample is insufficient for analysis

- In case the defect is of the first class

- If the administration's director orders so  

In some cases, it may request for samples of other products from the same manufacturer, based on the employee in charge of the evaluation of defect which may include several products or under the guidance of director of administration. Moreover, in case the absence of reference samples with the agent, samples from the manufacturer are required.

After the release of the analysis results:

- If the results of the analysis conform to the specifications, the National Centre for Vigilance announces the product safety and closes the report in quality management database, or replies to the informer.

- If the result of the analysis does not meet the specifications of the analysis, the product's company is requested to provide a scientific report detailing the defect reasons and the precautionary procedure.

After the arrival of the detailed report from the company, there are two scenarios:

1. Case one: the report confirms the defect in samples, then the recall process is initiated.

2. Case two:  the company states in the report that after samples analysis and reviewed, they were safe. Then reference samples are sent to the medicine sector's laboratory in order to be analysed, and after the results are obtained, the following is done:

If the reference samples confirm the specifications, the National Centre for Vigilance will consider if the defects in medicine may refer to storage conditions or transportation process. If the results show that the reference samples do not conform to the specifications, a recall process is initiated and the report in quality management database closed (SFDA, 1438H). The product is recalled by addressing product agent and requesting a recall non-confirming product batches. Then, a circulating letter is created and sent to all health authorities and its branches in the Kingdom regarding the recall procedure and to stop using non-confirming product, and then data related to recalled product is filled in the shared file database. The recall procedure is as follows:

- Receive a letter from the agent or the company stating the quantities of the existing product in the market or from health authorities and the action taken by them.

- Send inspectors to the market to ensure that the product is no longer available and that the company has completed the recall process.

- The SFDA will follow-up with the product agent and the director of the Scientific Office to ensure that the recall process is completed, in case the company does not complete the recall process within the period specified by the SFDA or in case of not responding after three letters from the SFDA, the Compliance and Enforcement Executive Management takes the necessary actions.

- After the recall process is ended, the company is requested to make an appointment for drug destruction with a medical waste company.

- After the arrival of the responding letter from the company that states the date of the destruction process, the letter is distributed to employee in storage and distribution departments to do the necessary to complete the verification.

-  After the end of the destruction process, the report closed and the data about recalled product filled in shared database files (SFDA, 1436 H).

2.5.4 Laboratory testing procedure

This section will illustrate the system of receiving, studying and analysing drug samples complaint in National Drug and Cosmetic Control laboratories in KSA.

' Samples should arrive with LIMS No. and complaint report that describe the complaint. Moreover, all samples should be checked for some items such as: the product name, LIMS No., batch No., dosage form, and storage conditions, and an adequate number of every batch should be delivered. For a bad storage complaint; the humidity, temperature, and the duration where samples exposed to those conditions should be mentioned in the report. If any of the above information is missing, SFDA should send E-mail to the reporter to complete the report.

' Head of the section should receive the complaint report and comment on it if necessary, and transfer the report with the samples to the coordinator in order to register the information.

' The sample will then be given an ID No. in order to be sent to the PMS (pharmaceutical monitoring system) unit supervisor to assign an analyst to analyse the sample.

' Analyst should then record observations in the sample logbook after examining it visually in order to decide which analysis should be performed on the sample.

' After discussing the test with the unit supervisor, analyst should decide the best test to conduct on the sample and document all information about the sample.

' Analyst should examine the sample and proceed with the physical tests.

' If a sample needs a biological assay, it should be transferred to the bio assay department.

' Analyst should document all specifications and results, then discuss these results with the unit supervisor.

After the unit supervisor approves the final results, he/she should write a report about the sample, which is then approved by the head of the section and lab manager with results and recommendations.

2.6 Comparison of recall procedures in US, UK, and KSA

Drug recall is a crucial decision for all companies. Each of countries (UK, US, KSA) have their specific guidelines for drug recall. The following Table 2.2 illustrates the differences in drug recall procedures between these three countries.

Table 2.2: Drug recall procedures in different countries

Parameters US UK KSA

Definition of drug recall Recalls are actions taken by a firm to remove a product from the market. These recalls may be directed by firms, by FDA request, or by FDA order under statutory power. Recall is a request to return to the maker, a batch or a whole product run of a product, normally because of the revelation of safety issues. Is a procedure in which a pharmaceutical product is removed from the pharmaceutical distribution and storage chain due to defects in the product.

Drug recall classification Three classes Four classes Three classes

Basis of classification Level of risk Classification rule Level of risk

Who needs to report Health professionals- Manufacturer, importer User- authorized representative- Manufacturer Manufacturer, product agent, and health professionals.

Recall Recall initiated by the Manufacturer. Recall initiated by the Manufacturer. Recall initiated by the Manufacturer.

Recall communication Telephones-Telegrams- Mailgrams- first classes letter approved by FDA. Telephones- Telegrams -fax. Telephones- mailgrams- e-mail.  

In United States, the Food and Drug Administration FDA is the agency that responsible for drugs recall guidelines. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency that responsible for the safety of medicines and medical devices (Rajput, 2016).

In Saudi Arabia, the SFDA is the government agency that is responsible for regulating and recalling medical products and devices. As can be seen, the drug recall process is fundamentally similar in all three countries. There are a few differences between the three countries in terms of recall definitions and accepted modes of communication. However, it can be concluded that the drug recall system in Saudi Arabia is in accordance with the international standards set by the US and UK drug recall systems.

3 Chapter Three: Methodology

3.1 Introduction

This chapter presents the research methodology used in this study. First, a basic explanation of the strategy is provided, followed by the methods that were used in the research, before reviewing the research approach in detail. The methods used for the sampling are outlined. An account of how data was collected and analysed is presented and discussed. Finally, the reliability and validity of the research tools employed in this work will also be discussed.

3.2 Research strategy

It is necessary to plan and design a research strategy, in order to find out possible answers to the research questions. So, the strategy must contain diverse types of tools and methods that are relevant to achieve the research objectives. In addition, it is important  to critically analyse and examine all material and data collection techniques.

The strategy for this research began by gathering background information about the study from appropriate literature, reviewing the guidance and procedures that are formulated by the Saudi Food and Drugs Authority (SFDA), then collecting data from questionnaires whose structure were based on the significant literature. After collecting data, the results were analysed and discussed. Finally, some conclusions were drawn based on the analysis of the collected data.

3.3 Research approach

The main objective of a research approach is to discover the answers to the research questions posed.  The research approach taken mainly determines the processes that are applied in order to reach the research results and outcomes (Cooper and Schindler, 2006). Thus, the research approach is mainly formed according to the researcher's attitudes and beliefs about the study. In general, there are different processes, strategies and methods used in a given piece of research to achieve the main objectives of the study. However, qualitative and quantitative approaches are the most used approaches.

' Qualitative approach:

This type of research approach mainly examines, collects and explains the collected data with reference to individuals' thoughts, attitudes and actions (Creswell, 1994). This approach mainly depends on interviews, case studies and content analysis to collect and analyse data. Therefore, the main focus of this approach is to gather in-depth data in order to have a good understanding of the research topics (Garson, 2001). This approach is a non-statistical approach because it aims to realize the research motivations and aims in a qualitative way (Creswell, 1994).

' Quantitative approach:

The quantitative approach mainly focuses on defining and collecting data using prepared surveys. It is also considered the most appropriate method to examine and understand unrealizable thoughts, motivations and acts. This approach uses deductive methods to test related subject theories through gathering and examining data (Bryman and Bell, 2007).

In order to achieve the objectives of the study, mixed methods were implemented by using both quantitative and qualitative methods. The qualitative research methods were used to analyse the drug recall system in Saudi Arabia in terms of its guidance and procedure, analysing policy framework and principles, as well as to discover Saudi Vigilance standards and to what extent it follows the quality control standards in the Kingdom and Saudi Arabia law and practice. On the other hand, quantitative method aims to gather information from questionnaires that were distributed to a sample of employees of the SFDA and pharmacists from public hospitals and medical supply in Saudi Arabia.

Creswell (2003) states that researchers who employ mixed methods in their research consider several methods and approaches to collect and analyse data, rather than just making a choice between two or more. Campbell and Fiske first used multiple methods in their study (Creswell, 2003), which encouraged other researchers to employ multiple approaches to collect data. Due to the nature of the current study and the questions that the researcher tried to answer, the researcher decided to employ mixed methods.  

3.4 Data sources

The research data can be collected using a variety of relevant sources and methods. The two main types of data sources are primary and secondary data sources. In the current research, the questionnaires and the content analysis are considered to be the primary data sources, while a literature review is the main source of secondary data. In order to provide sufficient and objective answers to the research questions, qualitative and quantitative data were obtained from both primary and secondary sources in this study.

' Primary data

The primary data is data that is directly collected by the researcher in order to achieve the research objectives. It can be defined as the intentionally constructed methods which are directly created by the researcher in order to answer the main question of the research (Malhotra and Birks, 2007), or it is the type of data that is collected from the research sample.

Primary data has several advantages that include a higher degree of accuracy due to being directly connected to the research topic, a more realistic view of the topic, and high reliability, as the data is largely collected from concerned and reliable entities.  

On the other hand, there are also a few disadvantages associated with primary data collection. Primary data collection generally requires a large amount of time and effort to collect the required data. Moreover, coverage of the instrument used to collect data is limited (such as surveys and questionnaires), so more researchers would be required to increase the coverage. Also, the data collection instruments needs to be selected and designed carefully, taking much time and effort.

' Secondary data

Secondary data is collected for a specific objective of the study but it does not cover the main problem of the research (Malhotra, Birks, 2007). In general, current and relevant literature is the commonly used secondary data source, as is the case in the current study.

The use of secondary data has several advantages. For example, it provides the researcher with a rich background on the study topic. It is also less time consuming to obtain, while it provides a lot of information. Moreover, it allows researchers to base their work on that of well-researched previous studies.  

However, there are also some disadvantages of secondary data such as its time sensitive nature. Secondary data can become outdated over time and may no longer be relevant so care must be taken to gather the most current and relevant literature. Care must also be taken to ensure that the secondary data does not bias or corrupt the research results. Finally, it can also result in some problems such as those related to copyright issues.

By considering the advantages and disadvantages of the two data sources, both primary and secondary data sources have been used in the current study along with the necessary care and precautions in order to provide appropriate coverage of the research topic.

3.5 Data collection techniques

For collection of primary data for this research, questionnaire and content analysis methods have been used. The questionnaire was developed based on the literature review in order to gain insight into the main strengths, weaknesses and opportunities for improvement that can be found in the drugs recall system in Saudi Arabia. The questionnaire also aimed to evaluate the effect of drug prescriptions on the ability of the drugs recall process, and the main obstacles faced by the SFDA employees in applying drugs recall system

The research used the questionnaire as it has many advantages including: the ability to establish, focus, and ask different questions in a clear manner and to collect the required data by methods that are considered easy to examine. Gill and Johanson (2002) stated that in order to achieve the objective of the questionnaire, there are some aspects needed to be addressed when preparing the questionnaire, which are: the questionnaire focus, the kind of response, the manner of the questions, and the organization and arrangement of the questions. The researcher created inquiries that are directly connected to the studied topic in order to have better understanding and achieve the study objectives.

The researcher designed two questionnaires which were designed to gather information from the two most relevant groups of the population: the pharmacists who dispense the drugs on a daily basis, and the SFDA employees who are responsible for enforcing and carrying out the drug recall.

The first questionnaire is about registering drugs prescriptions, in which it aims to collect information from pharmacists in public hospitals and medical supply in Saudi Arabia about registering drug prescriptions. The questionnaire consists of three sections; the first section aims to collect demographic data from the participants such as their age, gender, qualification and experience. The second section includes (7) items aims to collect managerial and pharmaceutical activities in the pharmacy. The last section includes (12) yes/no questions about registering drug prescriptions

The second questionnaire was distributed to SFDA employees in order to investigate the main obstacles that face these employees in the drug recall process. The questionnaire consists of two sections; the first section aims to collect demographic information about SFDA employees such as: age, gender, educational level and experience. The second section is about challenges that face SFDA employees in applying drug recall system; it includes 13 items in addition to two open-ended questions.

The second technique to collect primary data is the content analysis technique. Content analysis is a method of analysing verbal, written and visual documents (Cole, 1988). It is also a systematic and objective means of describing and quantifying phenomena (Downe-Wamboldt, 1992; Sandelowski, 1995).

The reason to conduct this type of research is that content analysis allows the researcher to test theoretical issues in order to enhance understanding of the data. Content analysis is a research method for making valid and replicable inferences from data to their context, with the aim of providing knowledge, a representation of facts, providing new insights and a practical guide to action (Krippendorff, 1980). In this study, the researcher reviewed the main guidance and procedures of the drug recall system in Saudi Arabia in order to know to what extent this system follows the quality control standards and to identify the opportunities for its improvement.

3.6 Population and sampling

The population targeted for this research were the SFDA employees as well as the pharmacists from public hospitals and medical supply in Makkah, Saudi Arabia. The sample consists of (103) SFDA employees and (63) pharmacists from public hospitals and medical supply in Saudi Arabia. The sample sets of respondents were selected randomly through convenience sampling method among the SFDA employees and pharmacists. In the convenience sampling method, the sample population is chosen for convenience due to limited available time and resources for the researcher. Thus, the sample does not represent the target population group but is sufficient to obtain the general sense of the target population. The researcher mainly selected pharmacists in the busy and heavily populated city of Makkah, Saudi Arabia in keeping with the study objectives. The sampling method also uses snowball sampling as the pharmacists were requested to share the questionnaires with other pharmacists in the region. This method of sampling has been shown to provide a more diverse sample population in the area for the study (Rubin and Babbie, 2010).

One limitation of the study was the smaller number of respondents, which was largely due to language barrier. As the questionnaires were printed and circulated in the English language only, many of the SFDA employees and pharmacists who were not fully comfortable in English did not participate in the survey. However, due to time and resource constraints, the questionnaire could not be provided in the regional language also.

3.7 Ethical Considerations

The questionnaires were administered to the pharmacists after clearly explaining the purpose of this project and the research objectives. Due the questions being of a sensitive nature, the pharmacists were assured of confidentiality and were not required to complete the questionnaire unless they were comfortable with the questions. To ensure the privacy and anonymity of the respondents, their names and other personal details were not gathered. They were also informed that the data would be strictly used for academic research purposes only, and would be deleted at the end of this study. Thus, the research included the necessary ethical considerations towards the participants.

3.8 Presentation and analysis of data  

The collected data was interpreted to produce useful insights. To process the collected data, it was entered into and analysed by the Statistical Package for the Social Sciences (SPSS). With the SPSS program, the frequencies of responses to numerous questionnaire items were tabulated for a large number of respondents. Basic descriptive statistics (Mean, Standard Deviations) and frequency distribution were computed for each variable.

3.9 Validity and reliability

Every scientific methodology needs to have credibility in terms of reliability and validity; these two terms are considered essential elements in any research. In general, validity can be defined as the researcher's ability to measure what they intend to measure in an accurate way. Whereas, reliability is the likelihood of a questionnaire to produce consistent answers (Kimberlin and Winterstein, 2008). In this section, the researcher will further critique these important two measures.

' Research validity:

According to Garson (2002), the validity of a research can be measured according to the accuracy of measuring the required topics and data of the research, in addition to the existence of any logical errors in the results and outcomes that are derived from the collected data. However, various steps were followed in order to ensure the validity of this study.

The research questions have been formulated accurately based on existing relevant literature. The data was collected from reliable sources, such as from SFDA employees and pharmacists from public hospitals and pharmacies. The questionnaire questions were designed based on previous literature and other existing references that are relevant to the research topic. For the degree of content validity of the prepared questionnaire, different academics were asked for their opinion about the questionnaire components, and the final copy was modified based on their observations. Moreover, before collecting data from respondents, the study's motivations and objectives were presented to assist respondents in obtaining a better understanding of what was required.

' Research reliability

Reliability is another measure that determines the ability to create the same outputs when applying the research instrument several times, either in different target audiences or different research areas (Garson, 2002). The main aim of this measurement tool is to ensure that if other researchers applied the same processes and used the same instruments, similar conclusions will be generated.

In general, responses to any questionnaire are varied because respondents have different values and opinions, not because the questionnaire items are unclear or confusing. Therefore, this study can be considered relatively reliable.

The following classification of Cronbach alpha values has been approved to judge the reliability of the questionnaires :

- Less than 2.5 is low

- From 2.5-3.5 is medium

- More than 3.5 is high

Cronbach's alpha values were computed to ensure the reliability of the questionnaires. The values are given in Table 3.1:

Table 3.1: Cronbach alpha values

No Variable Cronbach alpha Item No

1 Pharmacists practice 0.838 7

2 Recall challenges 0.604 13

Table 3.1 shows that the Cronbach alpha value was 0.84 for "Pharmacists practice", and 0.60 for "Recall challenges". These values indicate that the questionnaires can provide reliable data.

3.10 Conclusion

This research was carried out in the framework of exploratory research with mixed methods, a qualitative approach seeking to evaluate the guidance and procedures that are formulated by the Saudi Food and Drug Authority. The quantitative approach aimed to collect data from questionnaires that were distributed to employee of SFDA and pharmacists from public hospitals and medical suppliers in Saudi Arabia.

4 Chapter Four: Results

4.1 Introduction

This chapter presents the findings of the study in order to evaluate the drugs recall system in Saudi Arabia. To cover the study objectives, two separate questionnaires were used to collect information from two relevant sample sets- pharmacists and SFDA employees.

The first questionnaire is titled as 'Registering drugs prescriptions' which aims directly to investigate the effect of drug prescriptions on the ability of the drugs recall in Saudi Arabia. This questionnaire was distributed to pharmacists in public hospitals and medical supply from Makkah, in Saudi Arabia. A total of 63 pharmacists responded to this questionnaire. The researcher mainly selected pharmacists in Makkah, Saudi Arabia due to the region being heavily populated with tourists and pilgrims during the Hajj and Umrah pilgrimages. As a result, the pharmacists are more busy with dispensing drugs in this region compared to others. Also, previous studies have indicated that pharmacists in Makkah tend to dispense drugs without prescriptions (Almaghrabi, 2016), thus it was considered an important issue to be investigated further. The researcher sent the questionnaires to the pharmacists in the region, and due to time constraints, requested them to share the questionnaire with other pharmacists. As a result, the questionnaire was also answered by pharmacists from nearby regions besides Makkah.

The second questionnaire is titled 'Drug recall challenges' and is targeted towards SFDA employees to determine the main obstacles faced by them during the drug recall process in Saudi Arabia. A total of 103 SFDA employees participated and provided responses to this questionnaire.

Bothe questionnaires were distributed to the sample and collected from them during the month of February, 2017. The data from the completed questionnaires were collected and statistically analysed through both descriptive and exploratory statistics. Tables and graphs of the participant responses were presented as part of the descriptive analysis, while the means, standard deviations and One Sample t-test were used as the exploratory analysis to determine the statistical significance of the results. The Statistical Package for Social Sciences (SPSS) software was used to conduct the required statistical analysis. The below sections will describe the results of the questionnaires in detail.

4.2 Respondents demographic profile

The two questionnaires first enquired about the participants' basic information such as age, gender, educational qualifications and work experience, because these factors can play a role in their performance as pharmacists and SFDA employees. The different variables mentioned in the first section of the both questionnaires will be presented first.

Questionnaire 1: Pharmacists

1. Gender: The respondents were asked to state their gender and their responses are shown below in Table 4.1 and Figure 4.1.

Table :4.1 Pharmacists Gender

Figure 4.1: Gender of Pharmacists

The above table shows that the majority (88.9%) of the respondents are male, and the female respondents are only 11.1%. The above figure also confirms this fact, and indicates that the gender of the highest portion of respondents is male. This sample is consistent with the general gender distribution of pharmacists in Saudi Arabia.

2. Age: The respondents were asked to state whether their age was less or more than 30, and their responses are shown below in Table 4.2 and Figure 4.2. the pharmacists age can indicate their level of experience and expertise, as young and new pharmacists may not be fully aware of the best practices and the drug recall system.

Table  4.2: Pharmacists Age

Figure 4.2: Age of Pharmacists

Both the above table and figure illustrate that the majority (81%) of the respondents were in the age group of 30 years or more, and only 19% of the respondents were less than 30 years. Since the respondents are generally in the older age category, they are likely to be more experienced and aware of the proper practices, and would constitute an appropriate sample for the purpose of the study.

3. Qualifications: The respondents were asked to state their educational qualifications under the categories of graduate, post graduate and professional.  Their responses are shown below in Table 4.3 and Figure 4.3. Higher qualifications would imply better informed and knowledgeable pharmacists.

Table 4.3: Pharmacists qualifications

Figure 4.3: Qualifications of Pharmacists

The majority (47.6%) of the pharmacists have a graduate degree, while 30% have a postgraduate degree and only 22.2% have a professional degree. Thus, all the surveyed participants have the qualifications to be a pharmacist, and a reasonably large sample segment has advanced degrees, meaning that they are likely well informed as pharmacy professionals.

4. Years of Experience: The respondents were asked about their work experience in terms of the number of years of experience. Their responses are shown below in Table 4.4 and Figure 4.4.

Table  4.4: Pharmacists experience

Figure 4.4: Number of years of experience for the Pharmacists

The above table and figure show that the largest group (46%) of the participants had work experience of 9 years or more. Another 19% of participants have about 6-8 years of work experience, followed by 25% of pharmacists with 3-5 years of experience. Only 9.5% of the respondents had less than 2 years of work experience. Thus, a reassuringly large segment of the pharmacists have many years of experience as pharmacy professionals and would be well aware of the pharmacy and drug recall practises.

5. Place of work: The respondents were asked to state where they worked.  Their responses are shown below in Table 4.5 and Figure 4.5.

Table 4.5: Pharmacists work place

Figure 4.5: The place of work of Pharmacists

The majority (69.8%) of the pharmacists worked in medical supply stores in Makkah, while only about 1.6% of the respondents worked in  Jizan Tech, Ireland, Clinic, Rabigh and PHCC in Jeddah. This is in line with the fact that the questionnaires were mainly circulated to pharmacists in Makkah. Since Makkah sees a large influx of tourists and pilgrims every year, the pharmacists in Makkah are likely to be dispensing a variety of drugs to a much larger population than pharmacists in other locations in Saudi Arabia, which would mean their greater familiarity with drug prescriptions and pharmacy practices. Also, as previously mentioned, the researcher requested the pharmacists in Makkah to share the questionnaire with other pharmacists. As a result, the questionnaire was also answered by pharmacists from nearby regions besides Makkah.

6. Computer usage at work: The respondents were asked to state whether they used a computer at work on a regular basis. Their responses are shown below in Table 4.6 and Figure 4.6.

Table 4.6: Pharmacists usage of computer at their work

Figure 4.6: Computer usage at work for Pharmacists

The majority (73%) of pharmacists claimed to use a computer at work, while only 27% of the respondents did not use a computer at work. The ability to use a computer at work is important for pharmacists in order to maintain proper records at the pharmacy of patients medicine records, drugs and drug prescriptions.

Questionnaire (2): SFDA Employees

The second questionnaire also enquired the age, gender, qualifications and work experience of the SFDA employees. The detailed responses are presented in the following section.

1. Age: The respondents were asked to state their age in three categories (less than 30, between 30-40 and more than 40 years), and their responses are shown below in Table 4.7 and Figure 4.7.

Table 4.7: SFDA employees age

Figure 4.7: Age of SFDA employees

The above table and figure show that most (66%) of the SFDA employees were aged between 30-40 years, 22.3% were less than 30 years and while only 11.7% of the employees were more than 40 years. Thus, the majority of SFDA employees are over 30 years and have been in the workforce for a reasonably long time.

2. Gender: The respondents were asked to state their gender and their responses are shown below in Table 4.8 and Figure 4.8.

Table 4.8: SFDA employees gender

Figure 4.8: Gender of SFDA employees

The above table indicates that 84.5% of the respondents are male, while 15.5% of the respondents are female. So the male participants constitute the vast majority of the study sample. The above figure also confirms this fact, and this is consistent with the gender distribution of the pharmacist respondents.

3. Educational Level: The SFDA employees were asked to state their educational qualifications under the categories of Bachelor's, Master's and Ph.D. degrees.  Their responses are shown below in Table 4.9 and Figure 4.9. Higher qualifications would imply better informed and knowledgeable pharmacists.

Table 4.9: SFDA employees' educational level

Figure 4.9: Educational level of SFDA employees

The largest group (47.6%) of respondents had a Bachelor's degree. About  (42.7%) of the surveyed SFDA employees have Master's degree, and the rest (9.7%) of them have a Ph.D. degree. Thus, all the SFDA employees have the basic qualifications, while a large sample segment has higher level degrees, indicating that the employees are well qualified and knowledgeable.

4. Years of Experience: The respondents were asked about their work experience in terms of the number of years of experience. Their responses are shown below in Table 4.10 and Figure 4.10.

Table 4.10: SFDA employees' work experience

Figure 4.10: Number of years of experience of SFDA employees

The responses show that the largest group of surveyed employees (44.7%) have worked at SFDA for (6-8) years. The second largest group has (3-5) years of experience and this constitutes 26.2% of the total respondents, while (21.4%) worked in the SFDA for (9 or more) years and the rest (7.8%) have worked for (0-2) years. So, most of the surveyed employees have many years of work experience at the SFDA and should be very familiar with the various regulations and drug recall practices in Saudi Arabia.

4.3 Findings related to Pharmacists practice

The second section of the questionnaire for the pharmacists enquired about their managerial and pharmacy-related practices. This section tries to assess if the pharmacists know and practice the specified guidelines related to medicine storage, proper drug dispensing and maintaining records of patients. Seven related questions were asked, and the pharmacists' responses are shown in Table 4.11. The means and standard deviations of responses regarding Pharmacists practice were also calculated, and included in Table 4.11.

Table 4.11: Means and standard deviation of responses for 'Pharmacists practice' related questions and total means (n=63)

No Items Mean Std. Deviation Rank Agreement Degree

1 Ensuring pharmacy is well supplied with medicines. 3.54 1.015 4 Medium

2 Ensuring that medicines are of good quality. 3.83 1.025 2 High

3 Ensuring appropriate storage conditions for medicines. 4.02 1.157 1 High

4 Assessing that a prescription is a legally valid. 3.46 1.189 5 Medium

5 Assessing appropriateness of medication for the individual. 3.43 1.146 6 Medium

6 Providing the patient with information regarding the medicine. 3.59 1.227 3 High

7 Keep records about the patients' medical conditions, medication and progress.   3.29 1.361 7 Medium

Total Means 3.59 0.838 - High

    

Table (4.11) shows the agreement or disagreement of the pharmacists to these 7 questions, as well as the mean and standard deviation of the responses related to Pharmacists practice. The total means for the statements about pharmacists practice is 3.59 which indicates a strong agreement of the pharmacists regarding the statements. Also, the total of the standard deviation value is 0.838, which is an acceptable deviation.

The studied sample showed the strongest agreement to the statement 'Ensuring appropriate storage conditions for medicines' followed by their agreement for the statement 'Ensuring that medicines are of good quality.' Pharmacists also strongly agreed with 'Providing the patient with information regarding the medicine.' and to a lesser extent with the statement  'Ensuring pharmacy is well supplied with medicines.'

The pharmacists showed moderate agreement with the following three statements: 'Assessing that a prescription is a legally valid', 'Assessing appropriateness of medication for the individual.' and 'Keep records about the patients' medical conditions, medication and progress.'

All mean values of the above statements relating to pharmacists practice were between 3.29-4.02, which indicates good agreement of the sample set regarding all the statements. Thus, the surveyed pharmacists state that they follow the proper procedures regarding the following pharmacy practices: providing appropriate storage conditions for medicines, ensuring availability of good quality medicines, providing medicines with the most important information for patients, availability of all medicines in pharmacy, ensuring that a prescription is legally valid, ensuring appropriateness of medication for the individual, and maintaining records of the patients' medical conditions, medication and progress.

One sample t-test: To determine the statistical difference between the sample mean and the hypothesized population mean, the One Sample t-Test was performed. The results of the test are shown in Table 4.12.

Variables No Mean Std. Deviation "t" value D.F Sig

Pharmacists practice 63 3.59 0.838 34.034 62 0.000

Table 4.12: Results of One-Sample t-Test with individual samples compared to overall average

Table (4.12) shows that the t-value was (34.03), and that the results related to Pharmacists practice are statistically significant ('' '0.05).

4.4 Findings related to drug prescriptions and drug recalls

The next section of the questionnaire enquired about the pharmacists' knowledge and practice of drug prescriptions related procedures and drug recalls, so that the effect of drug prescriptions on the drug recall system can be evaluated. For this purpose, a series of questions related to drug prescriptions, registering prescriptions, and drug recalls were asked, and the pharmacists' responses are listed in Table 4.13.

Table 4.13: Frequencies and percentages of the surveyed Pharmacists' responses on registering drug prescriptions

Items Categories Frequency Percent

Is an electronic record made on the patient medication record each time a prescription is supplied to a patient? Yes 32 50.8

No 31 49.2

Total 63 100.0

Is the prescription register report printed on daily basis? Yes 35 55.6

No 28 44.4

Total 63 100.0

Is the prescription register report dated and signed by the pharmacist? Yes 48 76.2

No 15 23.8

Total 63 100.0

Is the prescription register report completed in the correct format according to the requirements? Yes 45 71.4

No 18 28.6

Total 63 100.0

Are the prescription register reports for the previous two years available for review at the premises? Yes 31 49.2

No 32 50.8

Total 63 100.0

Are they valid and up to date? Yes 40 63.5

No 23 36.5

Total 63 100.0

Have they been entered correctly into the prescription register? Yes 45 71.4

No 18 28.6

Total 63 100.0

Do you have strong information about drug recall process? Yes 32 50.8

No 31 49.2

Total 63 100.0

Do you know the reasons for applying recall for drugs? Yes 38 60.3

No 25 39.7

Total 63 100.0

Do you know the main types of drugs recall and the differences between them? Yes 38 60.3

No 25 39.7

Total 63 100.0

Do you know the specific steps that should be taken to recall the drugs? Yes 36 57.1

No 27 42.9

Total 63 100.0

In your opinion, do registering drug prescriptions enhance the drug recall process? Yes 44 69.8

No 19 30.2

Total 63 100.0

Based on the responses for the 12 questions shown in Table (4.13), the following results are derived:

' For the question (Is an electronic record made on the patient medication record each time a prescription is supplied to a patient?), only half (50.8%) of the respondents agreed that they followed this practice, while the remaining half (49.2%) do not follow this practice. Thus, it can be concluded that only 50% of the pharmacists follow the proper practice of recording the patient medication record each time a prescription is supplied to a patient. Clearly, this is a practice that needs to be improved.

' For the question (Is the prescription register report printed on daily basis?), more than half of the pharmacists (55.6%) agreed that they did, while the rest (44.4%) said that they do follow this practice. It can be concluded that while many pharmacists realize the importance of keeping the prescription register report every day for their patients, this practice needs to be further improved by the remaining pharmacists.

' For the question (Is the prescription register report dated and signed by the pharmacist?), the majority (76.2%) of the respondents stated that they followed this practice, while only 23.6% did not agree with this question. It can be concluded that the majority of pharmacists dated and signed the prescription register report, which means that they realize the importance of dating and signing the prescription register report for their patients. Thus, this action will have a positive effect on the ability of the drugs recall in Saudi Arabia.

' For the question (Is the prescription register report completed in the correct format according to the requirements?), the majority of pharmacists (71.4%) agreed that they did so, while the rest (28.6%) do not follow this practice. So, most of the pharmacists complete the prescription register report in the correct format according to the requirements, which means that they realize the importance of accurately completing the prescription register report in the correct format according to the requirements. This indicates that registering drug prescriptions will have a positive effect on the drug recall system.

' For the question (Are the prescription register reports for the previous two years available for review at the premises?) only half of the respondents  (50.8%) agreed that they did so, while the remaining half (49.2%) said that they do not follow this practice. It can be concluded that all pharmacists do not keep the prescription register reports for the previous years for review at the premises, which means that they do not realize the importance of availability of the prescription register reports of their patients for the previous years for review at the premises. Thus, this action will have a negative effect on the drug recall system in Saudi Arabia.

' For the question (Are they valid and up to date?), the majority of participants (63.5%) agreed, while the rest (36.5%) stated that they did not follow this practice. So, while the majority of pharmacists keep the prescription register reports valid and up to date, the other pharmacists need to also follow this procedure.

' For the question (Have they been entered correctly into the prescription register?), the majority of participants (71.4%) agreed while 28.6% did not follow this practice. Thus, most pharmacists entered the drug prescriptions correctly into the prescription register, which means that they realize the importance of correctly recording data into the prescription register of their patients. This indicates that registering drug prescriptions will have a positive effect on the drug recall system.

' For the question (Do you have strong information about drug recall process?), about half of the participants (50.8%) agreed, while the other half (49.2%) stated that they did not have this important information. Thus, only half of the surveyed pharmacists know enough about the drug recall process, while the others need to improve their knowledge and understanding of the drug recall process. This result will have a negative effect on the drug recall process in Saudi Arabia, as the pharmacists need to be well aware of it.

' For the question (Do you know the reasons for applying recall for drugs?) question, the majority (60.3%) agreed while the rest (39.7%) did not know the reasons for drug recalls. Again, this indicates an area for improvement.

' For the question (Do you know the main types of drugs recall and the differences between them?), the majority (60.3%) agreed while the rest (39.7%) did not know this information. So, while many pharmacists know the main types of drugs recall and the differences between them, the others need to be made aware of this information..

' For the question (Do you know the specific steps that should be taken to recall the drugs?), the majority (57.1%) agreed while the rest (42.9%) did not know this information. It can be concluded that all Pharmacists do not know the specific steps that should be taken to recall the drugs, and this area needs improvement.

' For the question (In your opinion, do registering drugs prescriptions enhance the drug recall process?) the majority of respondents (69.8%) agreed, while only 30.2% did not agree with this statement. It can be concluded that most Pharmacists believe that registering drug prescriptions would enhance the drug recall process. Therefore, there will be a positive effect of the drug prescriptions on the ability of the drugs recall in Saudi Arabia.

4.5 Findings related to drug recall challenges

The second questionnaire for the SFDA employees enquired about their knowledge of the drug recall system, and what were the challenges faced by them in applying the drug recall process. For this purpose, 13 different questions were included and the responses of the SFDA employees are listed in Table 4.14.

No Items Mean Std Dev Rank Agreement Degree

1 The drug recalls process in Saudi Arabia is satisfactory 3.34 1.081 11 Medium

2 Drug recalls can be a complex process. 3.63 1.057 6 High

3 The drug recalls process is very costly. 3.55 1.109 9 High

4 Multi-location of pharmaceutical companies has added complexity to supply chains and drug recalls.   3.61 1.059 7 High

5 Unclear data from manufactures is one of the challenges that drug recalls face.   3.70 1.188 5 High

6 The process of drugs recall in Saudi Arabia is slow. 3.45 1.127 10 Medium

7 The process of drugs recall in Saudi Arabia is ineffective. 2.50 1.119 13 Medium

8 Recall check strategies in SFDA is unclear. 2.90 1.241 12 Medium

9 Lack of correct data or missing information is one of the challenges faced in applying the recall system effectively. 3.88 0.993 2 High

10 The SFDA has detailed criteria for evaluating recall process.   3.57 1.126 8 High

11 Expansion of the Kingdom and the lack of branches in some areas are challenges faced in applying product recall. 3.83 1.024 4 High

12 There is lack of connection with patients which makes it hard to inform them of the recalled drugs. 4.02 1.019 1 High

13 Pharmacies and other health institutions are not subjected to the SFDA supervision; therefore, it is difficult to pursue their commitment to stop selling recalled drugs. 3.87 1.177 3 High

Total Means 3.53 0.460 - High

Table 4.14: Mean and standard deviation of responses for 'recall challenges' related questions and total mean (n=103)

Descriptive statistics were collected regarding the recall challenges, with mean and standard deviation of the responses. Table (4.14) shows that the total mean of the statements about recall challenges is 3.53, which indicates that there is strong agreement of SDA employees regarding the statements. Also, the total of the standard deviation value is (0.460), which is a usual value.

The responses in the above table show that the SFDA employees strongly agree with the statement "There is lack of connection with patients which make it hard to inform them of the recalled drugs", followed by  "Lack of the correct data or missing information is one of the challenges faced in applying the recall system effectively." They also strongly agreed with the statements 'Pharmacies and other health institutions are not subjected to the SFDA supervision; therefore, it is difficult to pursue their commitment to stop selling recalled drugs' and 'Unclear data from manufactures is one of the challenges that drug recalls face'.

All mean values of the above statements regarding to recall challenges scored between 2.50-4.02, which reflects good agreement of the sample set regarding all statements. Thus, the SFDA employees indicated that there are several recall challenges faced by them in applying the recall system effectively including lack of connection with patients, lacking of correct data or missing information, expansion of the Kingdom and the lack of branches in some areas, pharmacies and other health institutions are not subjected to the SFDA supervision, unclear data from manufactures, multi-location of pharmaceutical companies, and that the drug recalls can be costly, complex and slow.

One sample T-test: The One Sample T-Test was used to measure the significance of the result that recall challenges are faced by SFDA employees in applying the recall system effectively. The results are shown in Table 4.15.

Table 4.15: Results of the One Sample T-Test with individual samples compared to overall average

Variables No Mean Std. Deviation "t" value D.F sig

Recall challenges 103 3.53 0.460 77.784 102 0.000

Table 4.15 shows that t-value was 77.78 with significance of 0.00, so this result is statistically significant ('' '0.05) about the recall challenges.

4.6 Summary

In summary, this chapter presented the results of this research. The responses of the pharmacists and the SFDA employees to the questions in the two different questionnaires were illustrated in the respective tables and graphs. The results included the demographic data from the respondents, as well as their responses to the questions related to the pharmacists' practice and the challenges faced by SFDA employees regarding the drug recall. These results will be discussed in detail and their implications will also be discussed in the next chapter.

5 Chapter Five:  Discussion and Recommendations

5.1 Introduction

This study focused on evaluating the drug recall system in Saudi Arabia through analysing the guidelines and framework for drug recalls set in place by the SFDA. Moreover, the actual state of the drug recall system was assessed through the practices and knowledge of pharmacists, as well as the survey of SFDA employees. This chapter discusses the main research results and the implications of these results. Moreover, several recommendations are derived from the results to help improve the drug recall system in Saudi Arabia. This chapter also presents the possible future work that can follow from this study, and concludes this dissertation with a brief summary.

5.2 Results Summary

The responses from the two questionnaires provided useful results about the on ground reality of the drug recall system in Saudi Arabia. Firstly, the results clearly indicate that the pharmacists are well qualified and well experienced. They also follow the basic pharmacy practices of ensuring proper storage and dispensing of drugs to patients. However, it was apparent that they lack sufficient information about the drug recall process. Moreover, their pharmacy practices in terms of drug prescription registering and maintaining proper records were not satisfactory, as determined by the percentage of respondents who agreed that they followed the proper record keeping. Clearly, this aspect needs improvement as proper records of the drug prescriptions and patient records can help make the drug recall process more effective.

However, the majority of pharmacists agree that drug prescription registering will help enhance the recall system. This indicates that the drug prescriptions will positively impact the drug recall system in Saudi Arabia, provided the prescriptions are registered properly.

The SFDA employees were also found to have several years of work experience and higher educational qualifications, in general. Thus, they are well informed and knowledgeable about the drug recall system and its execution. They believe the drug recall system in Saudi Arabia is effective. However, the SFDA employees agree that they face several challenges in applying the drug recall.

The results showed the following specific practices and behaviour:

' There is a strong relation between the drug prescriptions and the effectiveness of the drug recall in Saudi Arabia.

' Pharmacists follow good practices concerning the following procedures respectively: providing appropriate storage conditions for medicines, ensuring availability of good quality medicines, providing the medicine with the most important information for patients, availability of all medicines in pharmacy, ensuring that a prescription is legally valid, ensuring appropriateness of medication for the individual, and maintaining records about the patients' medical conditions, medication and progress.

' Pharmacists generally realize the importance of registering drug prescriptions, and they largely agree that they maintain the prescription registers as per requirements.

' However, a large section (approximately half) of the pharmacists admit that they do not follow the below practices:

- Recording the patient medication record each time a prescription is supplied to a patient.

- Printing the prescription register report on daily basis.

- Keeping the prescription register reports for the previous years for review at the premises.

' Moreover, the pharmacists responded that they do not have sufficient information regarding:

- the overall drug recall process.

- reasons for applying recall for drugs.

- the main types of drugs recall and the differences between them.

- Knowing the specific steps that should be taken to recall the drugs.

' Pharmacists believe that registering drugs prescriptions will enhance the drug recall process, so they realize the importance of registering drug prescriptions.

' There are several challenges faced by the SFDA employees in the drug recall process such as the lack of connection with patients which makes it hard to inform them of the recalled drugs. Moreover, the lack of correct data or missing information is one of the challenges faced by the SFDA employees in applying the recall system effectively.

' Moreover, the SFDA employees indicated the below challenges faced by them in applying the recall system effectively:

- expansion of the Kingdom and the lack of branches in some areas

- pharmacies and other health institutions are not subjected to the SFDA supervision; therefore, it is difficult to pursue their commitment to stop selling recalled drugs

- unclear data from manufacturers

- drug recalls can be a costly, slow and complex process

- multi-location of pharmaceutical companies has added complexity to supply chains and drug recalls.

' There is a statistically significant effect ('''0.05) of the drugs prescriptions on the effectiveness of the drugs recall in Saudi Arabia.

' The obstacles faced by SFDA employees in the drug recall process are statistically significant ('''0.05).

5.3 Discussion

The main aim of the present study was to evaluate the drugs recall system in Saudi Arabia through reviewing its guidance and procedures formulated by Saudi Food and Drug Authority. In order to achieve the objectives of the study, mixed methods were implemented by using both quantitative and qualitative methods.

The qualitative research methods provided useful results from pharmacists and SFDA employees to identify the strengths and issues in the drug recall system, as described in the earlier section. The SFDA employees were selected for the questionnaires because  their level of involvement in the drug recall process is of crucial importance to the effectiveness of the drug recall. Also, it is important to determine their level of qualifications, experience and knowledge level, and finally, to obtain their valuable inputs based on their experience regarding the problems and challenges they face on a regular basis to implement and enforce the drugs recall system in Saudi Arabia.

Regarding the decision to include pharmacists in this study, previous studies have indicated that there is a general practice among pharmacists in Saudi Arabia to dispense drugs without valid prescriptions. The Saudi Food and Drugs Authority (SFDA) regulations require that the pharmacists should dispense all drugs on prescription only, with the sole exception of over-the-counter drugs (OTC) (Bawazir, 1992). However, several previous studies have shown that this is not the case as many pharmacists continue to dispense drugs without valid prescription.

In one study, it was found that more than 85% of the pharmacies in Saudi Arabia sell drugs without prescription (Al-Freihi et al., 1987). Another study found that more than 35% of medications sold without prescriptions were supposed to be sold only with prescriptions (Bawazir, 1992). In a large study of 60 pharmacies in Saudi Arabia, it was found that most of the pharmacies sold a variety of powerful drugs such as antibiotics and anti-psychotic drugs without doctors' prescriptions (Al-Mohamadi et al., 2013).

A study by Bahnassi (2014) found that many pharmacists in Saudi Arabia did not consider unauthorised dispensing of antibiotics to be a problem. The pharmacists who were surveyed admitted that there was a lack of implementation of the policies and regulations relating to dispensing of medicines. Therefore, this study clearly indicates that pharmacists have a definite lack of information and understanding about the proper regulations and their need to follow them. So, the SFDA regulations regarding pharmacists and their practice have to be stricter.

Especially, regions with a high flux of tourists and visitors such as Makkah, Saudi Arabia have been shown to have unregulated dispensing of antibiotics by pharmacists (Almaghrabi, 2016). Thus, it was important to assess whether this practice is still prevalent. For this purpose, the questionnaires were mainly distributed to the pharmacists in Makkah in this study.

The qualitative research methods were used to analyse the content of the recall drugs system in Saudi Arabia in terms of its guidance and procedure, by analysing the policy framework and principles. These will be discussed below in the context of the results obtained from the questionnaires.

5.4 Evaluation of the drugs recalls system

Drugs are essential to ensure the health of the general population. However, it must be ensured that the prescribed drugs are safe and effective with high quality standards. The drugs should be properly regulated throughout their development, production, importation, and distribution stages to ensure their safety and quality (Chan, 2013; Lembit and Budiono, 2008).

Yet, there are defective drugs appearing on the market on a regular basis. This is reflected in the increased number of drug recalls throughout the world. For instance, 426 drugs were recalled by the FDA in 2008, while 1,742 drugs were recalled the next year in 2009 (Levine and Cox, 2010; Kavilanz, 2010).

Keeping in mind the rapid development of medical technology and the increasingly large variety and number of drugs entering the market, it is necessary to have in place a system for monitoring the drugs in market and instituting a process to withdraw them from the market in case of defects or other safety issues. Thus, the drug recall process is an important system to safeguard public safety and ensure compliance of manufacturers.

Saudi Arabia has a well-established system in place for the drug recalls, which is under the purview of the Saudi Food and Drug Authority (SFDA). The SFDA is the main local administrative power which monitors and controls all matters related to food, drugs and medicinal devices in order to ensure the public health and safety in Saudi Arabia. The Drug Sector of the SFDA uses the basic standards for drugs identification process and guidance from the drug manufacturers to track and check the safety of the drugs. The pharmaceutical manufacturers are also required to set up an Institutional Audit Board (IRB) and a Data and Safety Monitoring Board (DSMB) to guarantee the safety of the products and maintain a strategic distance.

The SFDA also requires that all new drugs be registered with the SFDA. The drug application is conducted through online submission of the application form, then the product file is delivered in person, and finally the drug samples are provided for testing at SFDA facilities or by other organizations.

The definition, classification, and process for drug recalls in Saudi Arabia are consistent with the those followed by other countries such as USA and UK. So, based on analysis of the SFDA guidelines and procedures for drug recalls, the recall process in Saudi Arabia is theoretically a good working system. However, these results must be taken together with the on-ground analysis of pharmacists and SFDA employees who are actually responsible for the effective implementation of the drug recall system.

Based on the qualitative results from the surveyed pharmacists and SFDA employees, several main points have emerged about the drug recall system in Saudi Arabia:

- The pharmacists do not have sufficient information about the drug recall process, why and when it is carried out, and how it is implemented. This is a big hurdle to be overcome, because unless pharmacists are fully aware of the drug recall process, they cannot fully comply with it or participate in the drug recall process. For this purpose, the SFDA or Health Ministry can undertake a program to educate and inform all pharmacists and medical suppliers of the drug recall procedures.

- Pharmacists follow good practices in general related to drug storage, drug dispensing, providing medicine information, and maintaining patient medical records. This is helpful to know that there is a good general drug related policy and framework in place which is being followed by the pharmacists. This would make it easier to ensure their cooperation in implementing the drug recall processes.

- Pharmacists agree that drug prescriptions will have an impact on the effectiveness of the drug recall system. This is because when drugs are mainly dispensed through prescriptions, and the prescriptions are registered, it will be easier to track any defective products as well as monitor whether all the defective products have been pulled off.

- Pharmacists agreed that they do not maintain the drug prescription records as stringently as required, which is a point to be addressed by the Health Ministry through providing specific guidelines for pharmacies, and better supervision over medical suppliers.

- SFDA employees believe that the drug recall system in Saudi Arabia is effective, yet it is costly, slow and complex. This is another point that can be addressed over the long term to simplify the process.

- SFDA employees identified several challenges that are faced by them in applying the drug recall system. These challenges range from insufficient or incorrect information from drug manufacturers to difficulty in communicating with customers, far flung locations of pharmaceutical companies and lack of nearby SFDA branches. All of these points can be addressed in the short term by the SDFA or the Health Ministry.

Thus, overall this research has delivered the main study objectives:

1. Evaluate the drug recall system in Saudi Arabia through its guidance and procedures- find strengths and weaknesses that need to be addressed.

2. Assess whether drug prescriptions can help improve the effectiveness of the drug recall system.

Having achieved the study goals, the next steps are to determine how the results can be used further. The following sections will discuss the recommendations for strengthening the drug recall system in Saudi Arabia, and also recommend some future research based on this work.

5.5 Recommendations

Based on the results of this work, the following recommendations are made for improving the drug recall system in Saudi Arabia:

1. Pharmacies and other health institutions should be brought under SFDA supervision, so as to pursue their commitment to stop selling recalled drugs.

2. Saudi Ministry of Health and Health managers must guide the Pharmacies to increase their attention to keep records about the patients' medical conditions, medication and progress.

3. Saudi Ministry of Health and Health managers must guide the Pharmacists to keep the prescription register reports for the previous years for review at the premises, and increase their understanding of the importance of these prescription register reports, and the effect on the drug recall in Saudi Arabia.

4. SFDA employees and Pharmacists must improve the connection with patients in order to make it easy to inform them of the recalled drugs.

5. SFDA employees and Pharmacists must record the correct data and include all relevant information of the patients and drugs.

6. SFDA must expand in the Kingdom through increasing the number of branches in some areas.

7. SFDA employees must obtain clear data from the drug manufacturers.

8. SFDA employees must try to make the drug recalls an easy process and applicable.

9. SFDA must call the multiple locations of pharmaceutical companies to decrease the complexity of supply chains and drug recalls, and try to simplify these process as much as they can.

10. Saudi Food and Drug Authority must decrease the cost of drug recalls process as much as they can.

11. Saudi Food and Drug Authority must increase the speed of drugs recall process as much as they can.

12. SFDA must clarify the drug recall process and strategies, and share the information with pharmacists and other relevant persons.

13. Facilitate and accelerate the connection with patients through utilizing new technologies.

14. Ensure availability of appropriate storage conditions for medicines to ensure their good quality and prevent defects.

5.6 Suggestions for further research

Based on the results, discussion and recommendations of the study presented above, the following topics could be suggested for further research:

' Conducting similar studies on a larger sample of SFDA employees and pharmacists in all regions of the Kingdom.

' Conduct studies on all SFDA employees in Saudi Arabia to assess the difficulties faced by them in applying the drugs recall system.

' Study the impressions or attitudes of pharmacists regarding quality control standards in Saudi Arabia.

' Study the challenges faced in applying the recall system in Saudi Arabia effectively and the methods to overcome them.

5.7 Limitations

This study has a few limitations, similar to other studies of this kind:

' It must be considered that the pharmacists and SFDA employees provided 'acceptable' answers fearing negative outcomes from their superiors despite being assured of confidentiality, which is likely in the case of surveys with sensitive questions. Thus, a larger or wider sample set and guaranteed anonymity would help obtain more accurate responses.

' The small number of respondents is another limitation of this study, which was mainly due to language barrier. Due to time and resource constraints, the  questionnaires were printed and circulated in the English language only. As a result, many of the SFDA employees and pharmacists who were not fully comfortable in English did not participate in the survey. For future studies, this limitation can be overcome by preparing the questionnaires in the regional language also.

' The research data was obtained through a single method (i.e. questionnaire). It would be better to employ multiple data collection methods (such as interviews, focus groups, etc.) to provide more in-depth responses and results.

' The pharmacists who were surveyed were all or mostly from Makkah. While this area was selected due to the higher flux of people and drugs coming through, it would be better to survey pharmacists in other parts of KSA also.

' The data for this study was confined to the drug recall system in one country KSA. Other nearby countries in the region could also be evaluated to obtain a broader picture.

' This research's measurement results were acceptable in terms of reliability and validity, but there is certainly a need for additional work to get better  data and results. Future research can be conducted to overcome these limitations.

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SFDA. Saudi Food and Drug Authority website, available from: https://www.sfda.gov.sa/ar/Pages/default.aspx. [accessed: 21 Dec. 2016].

Shewale, S., Chavan, M., and Parekh, S., (2014). Pharmaceutical Product Recall:  Lesson Learned. INTERNATIONAL PHARMACEUTICAL INDUSTRY, 6(1), 1-23.

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Appendix 1: Survey Questionnaire 1

Registering drug prescriptions

The researcher conducted a study aims to evaluate the drugs recall system in Saudi Arabia, one of the study aims is to investigate the effect of the drugs prescriptions on the ability of the drugs recall in Saudi Arabia. Therefore, this questionnaire is about registering drugs prescriptions. It aims to collect information from pharmacists in public hospitals and medical supply from Makkah in Saudi Arabia about registering drug prescriptions. All information will be used just for academic purposes. It will take a period that ranges between 5 to 10 minutes to complete this questionnaire.

Thank you for your cooperation

Section (1): Background information

Please answer the following questions:

- Gender:             a) Male                    b) Female

-  Age:                 a) Less than 30 years.      b) 30 years or more      

- Qualification:

b) Graduate

c) Post graduate

d) Professional

- Your experience?

a) Less than 2 years

b) 3-5 years

c) 6-8 years

d) 9 years or more

- Where do you work?

a) In a hospital, hospital name ''''''''''''..

b) In medical supply in Makkah at Saudi Arabia.

- Do you use a computer at your work?

a) Yes

b) No

Section (2): Pharmacists practice

This section is about your managerial and pharmaceutical activities in the pharmacy. This section includes (7) items and beside each one five numbers indicated how strongly the item describes your practice at work, where 1= never, 2= rarely, 3= sometimes, 4= very often, 5= always.

No. Item 1 2 3 4 5

1 Ensuring pharmacy is well supplied with medicines.

2 Ensuring that medicines are of good quality.

3 Ensuring appropriate storage conditions for medicines.

4 Assessing that a prescription is a legally valid.

5 Assessing appropriateness of medication for the individual.

6 Providing the patient with information regarding the medicine.

7 Keep records about the patients' medical conditions, medication and progress.  

Section (3): Registering drugs prescriptions

This section includes (12) items, and beside each one two answers (yes/no). Please put (') under the appropriate answer.

No. Item Yes No

1 Is an electronic record made on the patient medication record each time a prescription is supplied to a patient?

2 Is the prescription register report printed on daily basis?

3 Is the prescription register report dated and signed by the pharmacist?

4 Is the prescription register report completed in the correct format according to the requirements?

5 Are the prescription register reports for the previous two years available for review at the premises?

6 Are they valid and in date?

7 Have they been entered correctly into the prescription register?

8 Do you have strong information about drug recall process?

9 Do you know the reasons for applying recall for drugs?

10 Do you know the main types of drugs recall and the differences between them?

11 Do you know the specific steps that should be taken to recall the drugs?

12 In your opinion, do registering drugs prescriptions enhance the drug recall process?

What are the main reasons for drugs recall? '''''..................................

Appendix 2: Survey Questionnaire 2

Drug Recall Challenges

The following questionnaire is part of a research about Drugs recall system in Saudi Arabia. As a SFDA employee, please fill the questionnaire in order to help the researcher to know the main obstacles you face in the drug recall process. The information in this questionnaire will be used for academic research only, the information will be held in confidential files, and no use of this information will in any way identify you as a participant.

Thank you for your cooperation

Section (a): Background information

Your age?

' Less than 30 years

' 30- 40 years

' More than 40 years

What is your gender?

' Male

' Female

What is your educational level?

' Bachelor's degree

' Master's degree

' Ph.D. degree or other advanced degree beyond a master's degree.

How long have you been working in the SFDA?

' 0-2

' 3-5

' 6-8

' 9 or more

Section (b): Recall challenges

For the following items, please indicate how strongly you agree with each item. Put (') bellow the number that best describes your opinion. (1=strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree).

No. Item 1 2 3 4 5

1 The drug recalls process in Saudi Arabia is satisfactory.

2 Drug recalls can be a complex process.

3 The drug recalls process is very costly.

4 Multi-location of pharmaceutical companies has added complexity to supply chains and drug recalls.  

5 Unclear data from manufactures is one of the challenges that drug recalls face.  

6 The process of drugs recall in Saudi Arabia is slow.

7 The process of drugs recall in Saudi Arabia is ineffective.

8 Recall check strategies in SFDA is unclear.

9 A lack of the right data or missing information is one of the challenges faced applying the recall system effectively.

10 The SFDA has detailed criteria for evaluating recall process.  

11 Expansion of the Kingdom and the lack of branches in some areas are challenges faced applying product recall.

12 There is lack of connection with patients which make it hard to inform them of the recalled drugs.

13 Pharmacies and other health institutions are not subjected to the SFDA supervision; therefore it is difficult to pursue their commitment to stop selling recalled drugs.

Other challenges you faced and did not mention above:

'''''''''''''''''''''''''''''''''

'''''''''''''''''''''''''''''''''

What are the main weaknesses of the SFDA recall system?

'''''''''''''''''''''''''''''''''

'''''''''''''''''''''''''''''''''

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