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Factors that affect the implementation of good distribution Practices: a comparative analysis of indigenous pharmaceutical companies in Nigeria and Ireland

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See discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/369625753Compliance With Regulatory Requirements And Their ImplementationRegarding The Storing And Distribution Of Pharmaceuticals In IndiaArticle in NeuroQuantology · November 2022DOI: 10.14704/Nq.2022.20.17.Nq88053CITATIONS0READS532 authors:Raju KamarajSRM Institute of Science and Technology6 PUBLICATIONS 4 CITATIONS SEE PROFILEPraveen Kumar S.SRM Institute of Science and Technology1 PUBLICATION 0 CITATIONS SEE PROFILEAll content following this page was uploaded by Praveen Kumar S. on 30 March 2023.The user has requested enhancement of the downloaded file.

Neuroquantology | November 2022 | Volume 20 | Issue 17 | Page 390-398 | Doi: 10.14704/Nq.2022.20.17.Nq88053 Praveen Kumar S, R Kamaraj,/ Compliance With Regulatory Requirements And Their Implementation Regarding The Storing And Distribution Of Pharmaceuticals In India, Us And Eu. eISSN 1303-5150 www.neuroquantology.com 390 Compliance With Regulatory Requirements And Their Implementation Regarding The Storing And Distribution Of Pharmaceuticals In India, Us And Eu. Praveen Kumar S, R Kamaraj1* Abstract Pharmaceutical distribution, storage, and warehousing are vital to an integrated supply chain management system. Good Distribution Practices (GDP) and Good Storage Practices (GSP) must be observed in all elements of pharmaceutical goods. Pharmacovigilance companies, agencies, and institutions play a significant role. Proper storage preserves medications’ efficacy and physical integrity. The storage and distribution of materials and commodities should comply with labelling and avoid degradation. The purpose is to ensure the quality, safety, and identification of pharmaceutical goods throughout the supply management cycle. Best practices in storage and transportation, refrigeration and temperature control, and maintaining optimal conditions at warehouses and pharmaceutical storage facilities. The regulatory status of storage and distribution practices in India, the United States and the European Union have been analysed. Despite differences in regulations, the essential concepts remain the same. Storage and transportation must be updated consistently to guarantee the proper distribution of products. Keywords: Good Distribution Practices, Good Storage Practices, Storage, Labeling, Warehousing, Transportation DOI Number: 10.14704/Nq.2022.20.17.Nq88053 Neuroquantology 2022; 20(17):390-398 INTRODUCTION The successful operation of an integrated supply chain management system is inextricably linked to the distribution of pharmaceutical products. The principles of Good Distribution Practices (GDP) and Good Storage Practices (GSP) must be adhered to in every facet of the activities involved in the distribution and storage of pharmaceutical products. The keywords GSP and GDP are sometimes used interchangeably because they are both components of the pharmaceutical product management chain and, as a result, are closely connected. Consequently, the terms GSP and GDP are frequently used interchangeably.[1]. Good Distribution Practice (GDP) Good Distribution Practice (GDP) outlines how to distribute human medicines. The Good Distribution Practice (GDP) is a quality assurance system that specifies protocols for the acquisition, custody, and shipment of therapeutic pharmaceuticals for human use.[2]. Principles and Applications The concepts outlined in the GDP should be implemented into national and international legislation and regulations to safeguard the uninterrupted flow of goods from the manufacturer to the dispensing organization. To transfer drugs up and down the distribution chain, there must be a collaboration between regulatory authorities, law enforcement agencies, customs agencies, pharmaceuticalmanufacturers, pharmaceutical dealers, and pharmacies.[3], [4]. *Corresponding Author:- Praveen Kumar S, R Kamaraj Address: 1*Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur-603203, Chengalpattu, Tamil Nadu, India, E-mail: [email protected] Relevant conflicts of interest/financial disclosures: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest

Neuroquantology | November 2022 | Volume 20 | Issue 17 | Page 390-398 | Doi: 10.14704/Nq.2022.20.17.Nq88053 Praveen Kumar S, R Kamaraj,/ Compliance With Regulatory Requirements And Their Implementation Regarding The Storing And Distribution Of Pharmaceuticals In India, Us And Eu. eISSN 1303-5150 www.neuroquantology.com 391 Good Storage Practices (GSP) Good Storage Practices (GSP) is a term from the field of quality assurance that describes the actions taken to keep a pharmaceutical product in pristine condition while it is being stored. Good Storage Practices (GSP) aims to keep medications in optimal condition and prevent any unwanted changes to their potency or purity.[5]. Principles and Applications The storage contains starting supplies, packaging materials, semi-completed or in-process components, and finished items ready to transport. Sanitation, temperature, humidity, and the light and ventilation system are factors that must be considered while securing goods (air supply). Segregation When items are properly stored, they are safeguarded from deterioration, contamination, and damage. For the displays, recorders, and failure alerts to work effectively, there must be temperature- and humidity-controlled spaces. When executing stock control activities on materials, it is crucial to prioritize those with the shortest lifespans. Materials and products should be routinely inspected to verify that they are in good condition have appropriate seals and labels, and that there is no major damage or the stuff contained within containers.[5]. Basic Prerequisites for the GDP and the GSP ➢ The roles, duties, and interdependencies of each employee must be specified. Detailing one’s obligations and commitments is crucial. Economic, political, social, or other issues or conflicts of interest shouldn’t affect generic medicines or generic pharmaceutical businesses’ services. ➢ Skilled and competent workers must meet GDP and GSP benchmarks. All employees, regardless of rank, should be trained on product security, counterfeit identification, and prevention. ➢ A quality system must have the right organizational structure, method, processes, and resources to ensure a product or service and its documentation meet quality requirements. ➢ Unauthorized individuals must be kept out of storage areas. All employees must follow corporate regulations and procedures for a safe, productive workplace. Always maintain your workplace clean and pest-free. ➢ Preparing vehicles and equipment for transporting, storing, or handling pharmaceutical commodities minimizes product contamination, stability, and package integrity. ➢ Pharmaceutical wholesalers must keep detailed records of everything they receive. Your records should include the following: ➢ Number of medications delivered or received, supplier’s name and location, date ➢ Storage conditions should be indicated on both the primary container and the mechanism used to close the container of the medicinal product. Depending on the situation, this information can be printed on the nearest suitable container, such as an ampule, or the container-closure system (a blister package) (e.g., carton). The outermost container must have storage conditions and environmental warnings. ➢ These acts can compromise the pharmaceutical supply chain’s safety and security and must be continuously monitored. ➢ Customer complaints should have a structured process. All complaints and other information regarding substandard or illegal pharmaceuticals must be thoroughly investigated. ➢ When an FDA-approved pharmaceutical product is suspected of being faulty or counterfeit, a documented process and qualified person in control of product recalls are necessary. If a recall is needed owing to a difficult-to-identify counterfeit product, the original manufacturer and health authorities should be contacted. ➢ GDP and GSP performance and compliance should be inspected to discover and remedy problems. Each identification’s repercussions should be noted. The final report should include all inspection results and suggestions. The project must be monitored effectively.[6], [7]. Good Storage and Distribution Practices (GSDP) Space is allocated for raw materials, notably pharmaceutical packaging to maximise output. This place is commonly referred to as a “warehouse” or “warehouse facility.” Objectives To ensure the secure, timely, and high-quality delivery of medications and medical supplies

Neuroquantology | November 2022 | Volume 20 | Issue 17 | Page 390-398 | Doi: 10.14704/Nq.2022.20.17.Nq88053 Praveen Kumar S, R Kamaraj,/ Compliance With Regulatory Requirements And Their Implementation Regarding The Storing And Distribution Of Pharmaceuticals In India, Us And Eu. eISSN 1303-5150 www.neuroquantology.com 392 from manufacturers to patients. In this procedure, three stages are involved: Figure 1. Stages Involved Prerequisites Products are safeguarded systematically. The minimum wall spacing is 50cm with adequate airflow. Products on shelves should be categorized. For each product, a stroke sheet should be arranged. Unopened cartons maintain product safety. Flammables should be stored separately. The place has been disinfected and medication & equipment handled carefully. Workers and inventory must be safe. Temperature, humidity, and air quality are key features of the GDSP. Discard improper items and educate patients about medication administration.[8]. Equipment Storage Spaces Initial inspections, cleanliness checks, and weight checks happen at the reception. Sample placement facilities should avoid cross-contamination. Chemical storage rooms and rooms for other specialized goods like AC and freezer items. Rejected items might be saved or discarded. Appropriate equipment can avoid cross-contamination in the dispensing area. Figure 2. Good Warehousing Practices in Regulated Countries [9] India Drugs and Cosmetics Act of 1940, and Rules of 1945, Schedule M Regulatory measures in India- GDP Medicines and cosmetics are sold, bought, distributed, and imported in India by the 1940 and 1945 statutes. Schedule M of the Act specifies excellent manufacturing procedures for pharmaceutical product deposits. Machinery and equipment must be stored in spaces created and suited for start-and-processing conditions, intermediate materials, final goods, and bulk, and quarantined, discharged, denied, despatched, or revoked items. Clean, dry, and at the right temperature are required. Submitted, monitored, and registered storage conditions (temperature, humidity) are required. Pest and vermin control processes need storage area housekeeping, rodent management, and reporting. Receiving and shipping bays must store supplies and items on adequate shelves, containers, and platforms. In Schedule M, the producer is responsible for protecting and stabilizing medications throughout shipping.[10]. Storage of Medications in a Warehouse ➢ The storage area must be well-protected, physically robust, and broad enough for safe storage and handling. Storage spaces need enough illumination for precise and secure functioning. ➢ Quarantined biological products, released, discharged, shipped, or revoked commodities, and counterfeit items must be segregated. ➢ Clean, dry, and temperature-controlled storage facilities and buildings must be developed or changed to ensure optimum storage conditions. ➢ Since they include biological materials, the receiving and dispatch bays must be safeguarded. Incoming organic containers must be cleaned before being stored, if feasible. ➢ Separate broken or damaged commodities from unusable supplies.[11]. Label Storage Condition ❖ Process medications and materials based on stability analysis labelling. All medications must be processed per label. ❖ Specific storage conditions must be listed on the product’s label. ❖ Stability tests verify the consistency of a drug or product, allowing for shelf-life predictions, correct storage, and labelling.

Neuroquantology | November 2022 | Volume 20 | Issue 17 | Page 390-398 | Doi: 10.14704/Nq.2022.20.17.Nq88053 Praveen Kumar S, R Kamaraj,/ Compliance With Regulatory Requirements And Their Implementation Regarding The Storing And Distribution Of Pharmaceuticals In India, Us And Eu. eISSN 1303-5150 www.neuroquantology.com 393 Stored Tablets/Capsules Storage labels: • Store product cold and dry and keep it free from light and moisture. • Keep the product away from light and moisture while storing it cool and dry. • Store in a dry, cold environment. • Keep in a cool, dry, dark location. • Capsules should be stored in a cool, dry location. Storage of Emulsions • In an airtight container, store emulsion away from light, heat, and freezing. Emulsions must be kept cold. Storage of Suspensions • Suspension should be kept cool and dry, not in the refrigerator. • Freezing should be halted at a very low temperature to prevent the agglomeration of suspended particles. Storage with labels • Put in a cool, dry place out of the path of both heat and light. • Keep the flask cold, dry, and at 30 degrees Celsius. • Keep at 25 degrees Celsius and out of the humidity. Storage of Ointments • Volatile ingredients should be kept in a firmly sealed jar. • The ointment should be kept cold and out of direct sunlight. Storage of Pastes • Store in a cold, well-sealed container to reduce humidity evaporation. Storage of syrups • The syrup should be kept in a corked, cold, dark container. The syrup shouldn’t exceed 25°C. • Keep cool and dry, out of direct sunlight. Storage of Oral Drops • Store in a cold, dry, light-restricted place. • Store out of direct sunlight at temperatures below 30°C. Storage of Injections • Keep in a cool, dark place where the temperature never gets above 25 degrees.[11]. UNITED STATES OF AMERICA (USA) United States – Food and Drug Administration It describes how to preserve a preparation’s integrity, including its look, before it reaches the client. Most things indicate storage conditions. Warehouses Tracking temperature differences in a warehouse over time helps generate a meaningful temperature profile that covers changes and conditions in different locations. These findings contain information on stocking and storing products. Configuration of Temperature Profiles Thermometers or other temperature-recording devices can be used to produce temperature profiles. Maximum and lowest temperatures should be recorded in 3 consecutive 24-hour periods. In temperature profiling, consider room size, space heater placement, sun-facing walls, low ceilings or towers, and warehouse location. Labelling, storage, and stability Pharmaceutical firms evaluate the most effective dose, side effects, delivery mode (oral, injectable, transdermal, etc.), overdosing effects, safety, and efficacy while designing drugs. Understanding storage impacts on preparation take time. These tests indicate if the drug is stable at room temperature, needs refrigeration, or must be frozen, and any storage deterioration. ❖ If no storage condition is chosen, a prescription drug may be stored at “controlled” room temperature to assure identity, potency, efficiency, and purity. ❖ Properly storing prescription pharmaceuticals requires manual, electromechanical, or electronic humidity and temperature monitoring tools and/or documentation. ❖ All stored medications must be documented. Buildings and Facilities Storage The drug’s storage temperature must be

Neuroquantology | November 2022 | Volume 20 | Issue 17 | Page 390-398 | Doi: 10.14704/Nq.2022.20.17.Nq88053 Praveen Kumar S, R Kamaraj,/ Compliance With Regulatory Requirements And Their Implementation Regarding The Storing And Distribution Of Pharmaceuticals In India, Us And Eu. eISSN 1303-5150 www.neuroquantology.com 394 within label restrictions. Drug product structures should be large enough for their intended purpose. This should avoid pollution-causing congestion. Buildings and facilities should be constructed to monitor environmental conditions and use easily-cleaned materials. Report sanitation and pest control frequency, materials, and processes. Software must be educated to manage storage conditions. Installations should have a fire, water, and explosive tests.[12]. USA Guidelines –GDP The USP includes labelling indications in its standards. Labelling needs stable data. In the EU, accelerated stability figures (e.g. 40%/75% RH) require a labelling declaration. Storage conditions should be considered when analysing transient temperature spikes exceeding the authorised ambient temperature range. “Effective Storage and Practice of Shipment” outlines pharmaceutical storage, distribution, and shipment. Transport requirements include: Travelers should avoid excessive heat or cold. Pre-calibrate temperature-calculating equipment. Items needing controlled room temperature storage must be transported in vehicles having an MKT no higher than 25°C. Vehicle design and extremes should reflect climate. Certification should contain 24-hour temperature charts for hot summer, normal, and cold winter days. Temperature cycling should be studied for commodities requiring particular storage conditions. Temperature cycling tests examine low- and high-temperature stability. Cold-chain commodities require temperature mapping.[12], [13]. Table 1. Requirements for safe warehousing and labelling in the USA Statements Regarding Labels Conditions for Storing Freezer -25°C to -10°C Refrigerator • Usually, 2 to 8°C. • If the MKT is below 8°C, 0-15°C excursions are permitted. Manufacturers may tolerate short-term rises of up to 25°C for 24 hours. • Transient spikes over 24 hours need stability data. Cool Place 8 to 15 °C Controlled room temperature • Typically, between 20 and 25 degrees Celsius. • If the MKT is less than 25°C, 15-30°C excursions are permitted. If the manufacturer allows it, short-term spikes up to 40°C for 24 hours are allowed. • Stability data must support short-term surges over 40°C. EUROPEAN UNION (EU)- EUROPEAN MEDICINES AGENCY (EMA) Distribution best practices (GDP) Maintaining medicine quality throughout the distribution process is possible thanks to a set of quality management procedures known as good distribution practices (GDPs). Good Storage Techniques (new) The implementation of reliable storage procedures is an essential component of quality control, as it serves to guarantee the correct maintenance of the medicinal products’ original levels of potency and efficacy during the storage process. Premises, Warehousing and Storage During transport, pharmaceuticals must be handled following “good storage practises” (GSP). The WHO Guide to Good Storage Practices (WHO Committee of Experts on Pharmaceutical Preparations. 37th report) provides more details on the standards for preserving pharmaceutical products in general (WHO Technical Report Series, No. 908, Annex 9). Storage areas ❖ Bulk and finished products are quarantined goods, and released, rejected, returned, or recalled goods require optimal storage conditions. Keep them clean, dry, and warm. Special storage conditions should be noted on labels (e.g., temperature, relative humidity). Cleaning and testing necessitate space between medications. ❖ Maintain secure and vermin-free storage places. A defined health programme should include cleaning frequency and techniques for premises and storage facilities. Implement a documented pesticide management strategy. It must not contaminate pesticides or medications. Appropriate waste-cleaning measures should be in place to avoid contamination. ❖ Receiving and shipping facilities should be weatherproofed. Until they’re handled, incoming pharmaceutical containers should be cleanable. ❖ Pollution and cross-contamination should be avoided when sampling in storage. Developing sample area cleaning techniques. ❖ Refused, expired, recalled, or returned products must be physically or electronically separated. The commodities and places must

Neuroquantology | November 2022 | Volume 20 | Issue 17 | Page 390-398 | Doi: 10.14704/Nq.2022.20.17.Nq88053 Praveen Kumar S, R Kamaraj,/ Compliance With Regulatory Requirements And Their Implementation Regarding The Storing And Distribution Of Pharmaceuticals In India, Us And Eu. eISSN 1303-5150 www.neuroquantology.com 395 be specified. ❖ Radiation, drugs, and other poisonous, sensitive, or dangerous medical products, as well as commodities that constitute a criminal, fire, or explosion risk, should be stored separately (e.g., fuel flukes, solids, and gas pressurization). ❖ The Good Manufacturing Practices (GMP) outlined below should be adhered to when handling pharmaceuticals. ❖ When handling and storing prescriptions, avoid contamination, mixing, and cross-contamination. ❖ Forbidden medications must be discovered and isolated before their fate is decided. ❖ Retailer adherence to national narcotics laws and regulations, as well as international narcotics treaties, is paramount. ❖ Those items that are broken or damaged should be separated from the rest of the stock and insulated. ❖ Storage facilities should be well-lit to ensure safe operations. Europe- European Commission- GDP The EU Standards on good distribution practice were established by the European Commission in 1994. (GDP). In March 2013, amended standards for storing or allocating medicines in the EU were issued, taking into account Directive 2011/62/EU. It replaces GDP guidelines in March 2013. Pharmaceutical wholesale distribution is crucial to integrated supply chain management. The distribution network for medicines is complex and has numerous actors. These rules outline the tools wholesalers should use to do business and prevent counterfeit medications out of the lawful supply chain. If these guidelines are followed, the safety and dignity of medications will be ensured. Directive 2001/83/EC defines wholesale distribution as “acquiring, keeping, providing, or exporting non-medicinal commodities to the public.” Importers, wholesalers, pharmaceutics, and anyone authorised to distribute medicines to the public will be engaged. Wholesalers need a licence. Distributors must meet GDP requirements per Directive 2001/83/EC Article 80(g). A manufacturing licence covers marketing licenced pharmaceuticals. Producers who engage in distribution will boost GDP. Wholesale distribution is a company’s presence or service in free zones and free storage locations[14]. Good Storage Techniques (new) Warehousing Sites Site Layout Natural disasters Recognizing natural dangers like flooding, landslides, and earthquakes, as well as extreme weather occurrences like hurricanes and tornadoes, is crucial when deciding where to locate storage facilities. To protect pharmacy personnel and drugs. Access to the website Storage facilities should include ample parking for large cars, especially emergency vehicles. The rationale behind this is to guarantee that the facility will run efficiently. Site safety is important Guard the perimeter of the property and the storage facilities from any intruders. Arson, robbery, or other criminal activities must be averted. The safety precautions should be suited to the location and value of the commodities. Condition of the site Remove dust, filth, garbage, and debris. Keep rodents off the job site. Regularly collected waste should be discarded in closed containers. Prevent dust, grime, and vermin in storage structures. Conditions of storage ❖ Stability test results used to create labels must be compatible with how medicines are typically stored. ❖ Separate storage is required for medicines and, if feasible, health commodities, as they are sensitive to light, heat, and moisture and must be protected from the elements. Products that require precise storage conditions require extra attention. ❖ Washing pharmaceutical product cans before putting them away in storage is recommended. ❖ Good stock security and safekeeping are the responsibilities of the warehouse. ❖ Preventing spills, breakdowns, corruption, and mix-ups requires proper medication handling and storage. ❖ Physical or technological separation of expiring and saleable medicines must be

Neuroquantology | November 2022 | Volume 20 | Issue 17 | Page 390-398 | Doi: 10.14704/Nq.2022.20.17.Nq88053 Praveen Kumar S, R Kamaraj,/ Compliance With Regulatory Requirements And Their Implementation Regarding The Storing And Distribution Of Pharmaceuticals In India, Us And Eu. eISSN 1303-5150 www.neuroquantology.com 396 provided. ❖ Regular stock inventories are required by law. Examine and record stock mishandling. Labeling and Contents of Storage Receptacles ❖ Storage and transportation in containers of all pharmaceutical items that do not impair the quality and protect against biological influences, such as microbial infection. Container labels must be clear, durable, indelible, and transparent. Labelling information should follow any national container labelling laws. ❖ Distributor etiquette should be written in at least one language. Shipping containers don’t need a detailed material summary to avoid theft, but they may contain processing and storage area specifics and protections to guarantee the product is always processed appropriately. ❖ If a pharmaceutical product is to be transported beyond the manufacturing system’s regulations, the producer’s name, address, special transport circumstances, and any regulatory provisions such protective symbols must be included on the label. ❖ Marking containers require worldwide and/or national abbreviations, names, or codes. ❖ Caution is suggested when using dry ice in cans. The medication product shouldn’t come into touch with dry ice for safety and effectiveness reasons. ❖ Broken containers should have written management instructions. Toxic and dangerous items get special scrutiny.[15], [16]. Table 2. Conditions of Storage, Labeling, and Testing in Europe Table 3. Comparison between GSP and GDP in India, the United States, and the European Union Sl.No. Parameters INDIA USA EUROPE 1. Regulation Rule 64 and 65 of the D&C Act 1945 describe medication sales and distribution. Other Regulations-WHO Annex 5 to USP 1083 (Supply Chain Integrity) 5th November 2013 GDP (2013/C343/01) 2. General Principle • GDP covers forward and reverse movement of drugs. • Assertion of consensus between all distribution intermediaries • Reduces illicit drug sales and promotion • The wholesaler must keep up a good QMS system. • A responsible person is chosen to follow the GDP and WDA. 3. Regulation of the distribution of pharmaceutical products • Activities are regulated by the government. • Pharmaceuticals must be imported and exported with permission. • If there is subcontracting, the standards must be the same as the original distributor. ND ND 4. Organization & Management • Responsible person selected for chainwide quality system • Responsible technical person corrects deviations. • Safety practices are monitored • Product quality is examined for adulteration, misbranding, and distribution pattern during importation. Must be sold lawfully. • Mandatory customer and supplier qualification. • Wholesale distribution is done by field distributors with a market authority. 5. Personnel • Standard Operating Procedures train and qualify personnel for GDP tasks. • Participants must wear clothing and take safety precautions. • Maintaining personal hygiene. ND ND 6. Quality System • Implementation of the appropriate CAPA • Inspection, auditing, and compliance certificate by external bodies • Deviations are noted and investigated • Maintain traceability documents. • Supply chain failure is reduced by risk assessment and management. • Effective supplier collaboration and distribution and risk-reduction cooperation are crucial. • Implement CAPA, validation, and change control • Required deviation documentation 7. Premises • Good Storage Practices are strictly followed when storing items. • Storage facilities are secure with enough illumination. • People are restricted from entering the storage facility. • Maintain a documented pest control and cleaning programme. • Cross-contamination is avoided by sampling in a clean location • Distribution process uses First Expiry First Out. • Extra safety is established for radioactive items, drugs, etc. ND • Equipment must be stored properly on-site • Validating important processes • The distribution method always follows a “first expire, first out” system 8. Temperature ND Temperature mapping protection measures should be in place to avoid fraud or manipulation of items in storage, eliminate unsold or underused inventory, and maintain records Temperature mapping protection measures should be in place to avoid fraud or manipulation of items in storage, eliminate unsold or underused inventory, and maintain records

Neuroquantology | November 2022 | Volume 20 | Issue 17 | Page 390-398 | Doi: 10.14704/Nq.2022.20.17.Nq88053 Praveen Kumar S, R Kamaraj,/ Compliance With Regulatory Requirements And Their Implementation Regarding The Storing And Distribution Of Pharmaceuticals In India, Us And Eu. eISSN 1303-5150 www.neuroquantology.com 397 9. Recall • System setup and monitoring • Returning fake medicine treatments Recall procedures must include all relevant documentation • System is installed and checked routinely • Instructions for returning potentially tainted medications 10. Returned product or falsified product ND ND • Suspected counterfeit pharmaceuticals are isolated by distributors and reported to MAH • Separately described, treatment medications should have a documented procedure 12. Equipment ND ND • Computerized system brings detailed equipment use • Only authorised employees enter information 13. Pricing of Product ND ND • Checks are needed to choose the right goods • The chosen item should have a long shelf life *ND- not defined CONCLUSION Based on publicly accessible documentation, this study indicates the current regulatory landscape for the storage and distribution of medications in India and a few other nations. The current regulatory status of storage and distribution procedures in India, the United States, and the European Union have been compared. While there is a larger degree of variation in the selected nations’ legislation, the concepts upon which they are based remain consistent. Considering India’s varied climates, the country needs laws that are both rigorous and practical to improve the storage and delivery of medicines. To tighten up the laws and guarantee the quality and safety of medicines in India, several proposals and suggestions have been made for enshrining them in Indian law. The procedure for carrying it out will be explained in full. The study accomplished all of its targets and objectives. ACKNOWLEDGEMENT All the authors are appreciated for their contribution and synthesis of the manuscript. DECLARATIONS Funding No funding was received for this work Conflict of interests Authors declare no conflict of interest amongst themselves. Ethical approval Since this work does not involve any animal studies it does not require Ethical approval REFERENCES F. Mawani, “Book review,” Soc Sci Med, vol. 62, no. 4, pp. 1042–1043, 2006. N. Kumar and A. Jha, “Pharmaceutical Good Distribution Practices – A Review of Global Scenario,” vol. 6, no. 12, pp. 1449–1452. S. Jeong and E. Ji, “Global perspectives on ensuring the safety of pharmaceutical products in the distribution process,” Int J Clin Pharmacol Ther, vol. 56, no. 1, pp. 12–23, 2018, doi: 10.5414/CP203151. Who, “Good distribution practices (GDP) for pharmaceutical products,” World Health, pp. 1–28, 2005. G. O. Elhassan et al., “Good Storage Practice in Pharmaceutical Manufacturing Plants in Khartoum State of Sudan,” Indo Global Journal of Pharmaceutical Sciences, vol. 04, no. 02, pp. 100–102, 2014, doi: 10.35652/igjps.2014.113. T. Moore, L. Kasonde, N. Konduri, and D. Lee, Assuring the quality of essential medicines procured with donor funds, no. April. 2012. K. E. Tairova, J. R. Dilbarkhanova, M. G. Rayisyan, V. D. Sekerin, and A. E. Gorokhova, “Aspects of improving the regulatory system of pharmaceutical products in the Republic of Kazakhstan,” Journal of Advanced Pharmacy Education and Research, vol. 10, no. 4, pp. 87–92, 2020. R. H. Bishara, “Cold chain management – An essential component of the global pharmaceutical supply chain,” Am Pharm Rev, vol. 9, no. 1, pp. 105–109, 2006. N. Kumar and A. Jha, “Application of principles of supply chain management to the pharmaceutical good transportation practices,” Int J Pharm Healthc Mark, vol. 13, no. 3, pp. 306–330, 2019, doi: 10.1108/IJPHM-09-2017-0048. K. N and J. A, “Regulatory Approach to Ensure Quality of Products – An Indian Perspective of Missing Linkage,” Pharm Regul Aff, vol. 05, no. 01, 2016, doi: 10.4172/2167-7689.1000163. K. Shafaat et al., “An overview: storage of pharmaceutical products,” World J Pharm Pharm Sci, vol. 2, no. 5, pp. 2499–2515, 2013, [Online]. Available: https://www.researchgate.net/profile/Brajesh-Kumar-23/publication/258833887_AN_OVERVIEW_STORAGE_OF_PHARMACEUTICAL_PRODUCTS/links/00b7d5290e8cc7ee09000000/AN-OVERVIEW-STORAGE-OF-PHARMACEUTICAL-PRODUCTS.pdf G. Distribution, S. For, P. In, and M. P. Venkatesh, “Journal of Global Trends in Pharmaceutical Sciences GOOD DISTRIBUTION AND STORAGE FOR PHARMACEUTICALS IN UNITED,” vol. 10, no. 4, pp. 6811–6817, 2019. N. Kumar and A. Jha, “Quality risk management during pharmaceutical ‘good distribution practices’ – A

Procedia Manufacturing 43 (2020) 336–3432351-9789 © 2020 The Authors. Published by Elsevier B.V.This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)Peer review under the responsibility of the scientific committee of the Global Conference on Sustainable Manufacturing.10.1016/j.promfg.2020.02.17010.1016/j.promfg.2020.02.1702351-9789© 2020 The Authors. Published by Elsevier B.V.This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)Peer review under the responsibility of the scientific committee of the Global Conference on Sustainable Manufacturing. Available online at www.sciencedirect.com ScienceDirect Procedia Manufacturing 00 (2019) 000–000 www.elsevier.com/locate/procedia 2351-9789 © 2019 The Authors, Published by Elsevier B.V. Peer review under the responsibility of the scientific committee of the Global Conference on Sustainable Manufacturing 17th Global Conference on Sustainable Manufacturing The headache of medicines’ supply in Nigeria: an exploratory study on the most critical challenges of pharmaceutical outbound value chains. Solomon Aigbavboa* & Charles Mbohwa Department of Quality & Operations Management, Faculty of Engineering & the Built Environment, University of Johannesburg 2006, South Africa Abstract The outbound segment of any product’s value chain is very critical in its delivery to the final consumer/customer. In this study, the pharmaceutical supply chains management in Nigeria with emphasis on the challenges of the outbound value chains was investigated. A quantitative survey of all the seven categories of both the private and public sectors of the Nigerian pharmaceutical industry was conducted. Data analysis shows six most critical challenges facing the delivery of medicines in Nigeria. Exploratory factor analysis of the data extracted two main factors out of challenges named “people & competency issues” and “infrastructural & regulatory inadequacies”. Valuable contributions from this study to knowledge, research methodology and policies have been made from the results of this study. The findings will be useful for policy and decision makers in both public and private sectors of the pharmaceutical industry in Nigeria and other resource-poor countries. Key words: Supply chain management, pharmaceutical outbound value chains, challenges of pharmaceutical outbound value chains © 2019 The Authors, Published by Elsevier B.V. Peer review under the responsibility of the scientific committee of the Global Conference on Sustainable Manufacturing Keywords: Supply chain management; pharmaceutical outbound value chains; challenges of pharmaceutical outbound value chains. 1. Introduction Efficient and effective supply chains for medicines and vaccines are very vital to the delivery of health services. Any functional health system requires supply chains that can ensure a consistent flow of affordable, good-quality medicines, * Corresponding author. Tel.: +234 803 343 8055. E-mail address: [email protected] Available online at www.sciencedirect.com ScienceDirect Procedia Manufacturing 00 (2019) 000–000 www.elsevier.com/locate/procedia 2351-9789 © 2019 The Authors, Published by Elsevier B.V. Peer review under the responsibility of the scientific committee of the Global Conference on Sustainable Manufacturing 17th Global Conference on Sustainable Manufacturing The headache of medicines’ supply in Nigeria: an exploratory study on the most critical challenges of pharmaceutical outbound value chains. Solomon Aigbavboa* & Charles Mbohwa Department of Quality & Operations Management, Faculty of Engineering & the Built Environment, University of Johannesburg 2006, South Africa Abstract The outbound segment of any product’s value chain is very critical in its delivery to the final consumer/customer. In this study, the pharmaceutical supply chains management in Nigeria with emphasis on the challenges of the outbound value chains was investigated. A quantitative survey of all the seven categories of both the private and public sectors of the Nigerian pharmaceutical industry was conducted. Data analysis shows six most critical challenges facing the delivery of medicines in Nigeria. Exploratory factor analysis of the data extracted two main factors out of challenges named “people & competency issues” and “infrastructural & regulatory inadequacies”. Valuable contributions from this study to knowledge, research methodology and policies have been made from the results of this study. The findings will be useful for policy and decision makers in both public and private sectors of the pharmaceutical industry in Nigeria and other resource-poor countries. Key words: Supply chain management, pharmaceutical outbound value chains, challenges of pharmaceutical outbound value chains © 2019 The Authors, Published by Elsevier B.V. Peer review under the responsibility of the scientific committee of the Global Conference on Sustainable Manufacturing Keywords: Supply chain management; pharmaceutical outbound value chains; challenges of pharmaceutical outbound value chains. 1. Introduction Efficient and effective supply chains for medicines and vaccines are very vital to the delivery of health services. Any functional health system requires supply chains that can ensure a consistent flow of affordable, good-quality medicines, * Corresponding author. Tel.: +234 803 343 8055. E-mail address: [email protected] 2 Author name / Procedia Manufacturing 00 (2019) 000–000 vaccines and other medical products at every level of the health service delivery points [1, 2]. The supply chain of pharmaceutical products in any health system is a top priority [3]. Pharmaceutical products are very valuable to health systems as alongside other healthcare services, they contribute to enhance quality of life by reducing morbidity and mortality rates. Pharmaceutical products differ from other commodities, given their form, composition and the purpose for which they are used. People depend on them for their health and sometimes, even for life itself [4]. An effective and efficient pharmaceutical supply chain is very vital in creating competitive advantages for companies. On the other hand, it has been described as challenging because of its complex nature and the strict government regulations in this field [5]. The efficiency and effectiveness of the entire value chain depend amongst others, specific issues related to people and lack of expertise and infrastructure. These issues are more prominent in the developing countries than the developed ones, posing a systemic challenge to the entire value chain. 2. Challenges of Pharmaceutical Supply Chains in Nigeria Over the years, the pharmaceutical supply chains in Nigeria and sub-Saharan Africa have faced many challenges which have impacted negatively on the performance of the chains. These challenges include but not limited to: Stock-outs Stock-outs in the pharmaceutical sectors have become a worldwide phenomenon and not restricted to countries of low- income levels in recent years. This trend can be a consequence of several causes, including, but not limited to procurement and supply chain management-related issues [6]. In a study to assess Primary Health Centre (PHC) facilities service readiness with focus of availability of essential drugs and medical equipment covering 2480 healthcare facilities from all the 6 geopolitical zones of Nigeria, Oyekale reported availability of some basic drugs as low as between 10.48 and 25.2% [7]. In Nigeria, stock-outs of basic medicines healthcare facilities have been reported [8]. Fake and counterfeit products The issue of fake and counterfeit drugs has become a global challenge and is now endemic in the various drug supply chains. Statistically, between 13 to 35% of worldwide sales of fake and counterfeit drugs come mainly from India, Nigeria and Pakistan [9] Disruptions Supply chains are exposed to disruptions consequential from various sources, factors and risks that hinder the performance of one or more of their constituent entities [10]. Some of risks are disruptions that physically prevent product flows and even in end-product failures across the supply chains [11]. Pharmaceutical supply chain management in disrupted counties where there are severe sectarian, tribal, religious conflicts and overall weak systemic governance can be very challenging [4]. The security challenge of the Boko Haram insurgency in North-East, Nigeria has had massive negative impacts on the regional pharmaceutical supply chains and healthcare delivery systems as destruction of facilities and sometimes killing of personnel are typical outcomes [12]. Expired Drugs Medicines are unlike some products which have no expiry dates. Medicines expire and lose potency. Accordingly, any incidence of expiration of medicine poses a critical problem across the pharmaceutical supply chain as it reduces the net quantity of medicines available to the patient(s) and hence the overall quality of healthcare [13]. The chaotic drug distribution system in Nigeria allows for easy occurrence of expired drugs in the pharmaceutical supply chains [14]. Some unscrupulous drug traders have been reportedly found re-packaging expired drugs from other countries to sell in Nigeria [15[.

Solomon Aigbavboa et al. / Procedia Manufacturing 43 (2020) 336–343 337 Available online at www.sciencedirect.com ScienceDirect Procedia Manufacturing 00 (2019) 000–000 www.elsevier.com/locate/procedia 2351-9789 © 2019 The Authors, Published by Elsevier B.V. Peer review under the responsibility of the scientific committee of the Global Conference on Sustainable Manufacturing 17th Global Conference on Sustainable Manufacturing The headache of medicines’ supply in Nigeria: an exploratory study on the most critical challenges of pharmaceutical outbound value chains. Solomon Aigbavboa* & Charles Mbohwa Department of Quality & Operations Management, Faculty of Engineering & the Built Environment, University of Johannesburg 2006, South Africa Abstract The outbound segment of any product’s value chain is very critical in its delivery to the final consumer/customer. In this study, the pharmaceutical supply chains management in Nigeria with emphasis on the challenges of the outbound value chains was investigated. A quantitative survey of all the seven categories of both the private and public sectors of the Nigerian pharmaceutical industry was conducted. Data analysis shows six most critical challenges facing the delivery of medicines in Nigeria. Exploratory factor analysis of the data extracted two main factors out of challenges named “people & competency issues” and “infrastructural & regulatory inadequacies”. Valuable contributions from this study to knowledge, research methodology and policies have been made from the results of this study. The findings will be useful for policy and decision makers in both public and private sectors of the pharmaceutical industry in Nigeria and other resource-poor countries. Key words: Supply chain management, pharmaceutical outbound value chains, challenges of pharmaceutical outbound value chains © 2019 The Authors, Published by Elsevier B.V. Peer review under the responsibility of the scientific committee of the Global Conference on Sustainable Manufacturing Keywords: Supply chain management; pharmaceutical outbound value chains; challenges of pharmaceutical outbound value chains. 1. Introduction Efficient and effective supply chains for medicines and vaccines are very vital to the delivery of health services. Any functional health system requires supply chains that can ensure a consistent flow of affordable, good-quality medicines, * Corresponding author. Tel.: +234 803 343 8055. E-mail address: [email protected] Available online at www.sciencedirect.com ScienceDirect Procedia Manufacturing 00 (2019) 000–000 www.elsevier.com/locate/procedia 2351-9789 © 2019 The Authors, Published by Elsevier B.V. Peer review under the responsibility of the scientific committee of the Global Conference on Sustainable Manufacturing 17th Global Conference on Sustainable Manufacturing The headache of medicines’ supply in Nigeria: an exploratory study on the most critical challenges of pharmaceutical outbound value chains. Solomon Aigbavboa* & Charles Mbohwa Department of Quality & Operations Management, Faculty of Engineering & the Built Environment, University of Johannesburg 2006, South Africa Abstract The outbound segment of any product’s value chain is very critical in its delivery to the final consumer/customer. In this study, the pharmaceutical supply chains management in Nigeria with emphasis on the challenges of the outbound value chains was investigated. A quantitative survey of all the seven categories of both the private and public sectors of the Nigerian pharmaceutical industry was conducted. Data analysis shows six most critical challenges facing the delivery of medicines in Nigeria. Exploratory factor analysis of the data extracted two main factors out of challenges named “people & competency issues” and “infrastructural & regulatory inadequacies”. Valuable contributions from this study to knowledge, research methodology and policies have been made from the results of this study. The findings will be useful for policy and decision makers in both public and private sectors of the pharmaceutical industry in Nigeria and other resource-poor countries. Key words: Supply chain management, pharmaceutical outbound value chains, challenges of pharmaceutical outbound value chains © 2019 The Authors, Published by Elsevier B.V. Peer review under the responsibility of the scientific committee of the Global Conference on Sustainable Manufacturing Keywords: Supply chain management; pharmaceutical outbound value chains; challenges of pharmaceutical outbound value chains. 1. Introduction Efficient and effective supply chains for medicines and vaccines are very vital to the delivery of health services. Any functional health system requires supply chains that can ensure a consistent flow of affordable, good-quality medicines, * Corresponding author. Tel.: +234 803 343 8055. E-mail address: [email protected] 2 Author name / Procedia Manufacturing 00 (2019) 000–000 vaccines and other medical products at every level of the health service delivery points [1, 2]. The supply chain of pharmaceutical products in any health system is a top priority [3]. Pharmaceutical products are very valuable to health systems as alongside other healthcare services, they contribute to enhance quality of life by reducing morbidity and mortality rates. Pharmaceutical products differ from other commodities, given their form, composition and the purpose for which they are used. People depend on them for their health and sometimes, even for life itself [4]. An effective and efficient pharmaceutical supply chain is very vital in creating competitive advantages for companies. On the other hand, it has been described as challenging because of its complex nature and the strict government regulations in this field [5]. The efficiency and effectiveness of the entire value chain depend amongst others, specific issues related to people and lack of expertise and infrastructure. These issues are more prominent in the developing countries than the developed ones, posing a systemic challenge to the entire value chain. 2. Challenges of Pharmaceutical Supply Chains in Nigeria Over the years, the pharmaceutical supply chains in Nigeria and sub-Saharan Africa have faced many challenges which have impacted negatively on the performance of the chains. These challenges include but not limited to: Stock-outs Stock-outs in the pharmaceutical sectors have become a worldwide phenomenon and not restricted to countries of low- income levels in recent years. This trend can be a consequence of several causes, including, but not limited to procurement and supply chain management-related issues [6]. In a study to assess Primary Health Centre (PHC) facilities service readiness with focus of availability of essential drugs and medical equipment covering 2480 healthcare facilities from all the 6 geopolitical zones of Nigeria, Oyekale reported availability of some basic drugs as low as between 10.48 and 25.2% [7]. In Nigeria, stock-outs of basic medicines healthcare facilities have been reported [8]. Fake and counterfeit products The issue of fake and counterfeit drugs has become a global challenge and is now endemic in the various drug supply chains. Statistically, between 13 to 35% of worldwide sales of fake and counterfeit drugs come mainly from India, Nigeria and Pakistan [9] Disruptions Supply chains are exposed to disruptions consequential from various sources, factors and risks that hinder the performance of one or more of their constituent entities [10]. Some of risks are disruptions that physically prevent product flows and even in end-product failures across the supply chains [11]. Pharmaceutical supply chain management in disrupted counties where there are severe sectarian, tribal, religious conflicts and overall weak systemic governance can be very challenging [4]. The security challenge of the Boko Haram insurgency in North-East, Nigeria has had massive negative impacts on the regional pharmaceutical supply chains and healthcare delivery systems as destruction of facilities and sometimes killing of personnel are typical outcomes [12]. Expired Drugs Medicines are unlike some products which have no expiry dates. Medicines expire and lose potency. Accordingly, any incidence of expiration of medicine poses a critical problem across the pharmaceutical supply chain as it reduces the net quantity of medicines available to the patient(s) and hence the overall quality of healthcare [13]. The chaotic drug distribution system in Nigeria allows for easy occurrence of expired drugs in the pharmaceutical supply chains [14]. Some unscrupulous drug traders have been reportedly found re-packaging expired drugs from other countries to sell in Nigeria [15[.

338 Solomon Aigbavboa et al. / Procedia Manufacturing 43 (2020) 336–343 Author name / Procedia Manufacturing 00 (2019) 000–000 3 Corruption The efficiency of healthcare delivery in any country is dependent on the judicious use of both human and financial resources to serve the sick population [16]. Corruption a big threat all aspects of national development. At a rank of 136 out of 176 by 2014; Nigeria is classified as one of the most corrupt nations in the world [17]. According to Transparency International, “corruption is everywhere: even the health and medical services, considered the least corrupt government institution, are considered very corrupt by 41 per cent of Nigerians”. In 2016, the Global Fund for the control of HIV/AIDs in Nigeria found widespread of corruption involving program funds running into millions of US Dollars [18]. Infrastructure Poor infrastructure has been identified as one of the significant structural barriers in the health systems of sub Saharan African countries [19]. In comparison with other economies like the middle- and high-income countries, Nigeria has one of the least-developed road networks with approximately 200 metres of roads per km2 pared compared to 1400 metres in high-income countries [20]. The supply chains of pharmaceuticals require steady, uninterrupted electricity for the storage and potency of thermolabile products like vaccines and antibiotics. The absence of a stable source of power also negatively affects certain aspects of the pharmaceutical supply chains especially the cold chains [21]. Weak regulatory systems Weak regulatory systems in many SSA impact negatively on the pharmaceutical supply chains. This is not only a challenge in itself, it also gives rise to a critical problem of poor quality medicines in the pharmaceutical supply chains. As high as 90% of national drug regulatory bodies in SSA are unable to effectively discharge their basic regulatory functions [22]. 3: Research gaps Many studies have been conducted on the Nigerian pharmaceutical industry but few on the supply chains and little or none on the challenges into the outbound value chains. Although the study by Isola & Mesagan [23] provided insights into the relationships and performance of the Nigerian pharmaceutical industry, it did not address the issues of supply chains in the industries. Findings from other studies have highlighted factors such as limited access to drugs [24, 25, 26] and fake drugs syndrome [15] as challenges associated with the pharmaceutical supply chains in Nigeria. Sieverding and Beyeler [8] undertook an extensive study on some channel players along chains. There exists no holistic empirical study on the challenges of both sectors of the industry. Furthermore, most of the previous studies have focused on one of the two sectors in the industry. This study aims to fill these research gaps. 4: Research question What are the challenges facing outbound pharmaceutical value chains in Nigeria. What problems limit the effectiveness of pharmaceutical organizations’ strategies of delivering medicines and other pharmaceutical products to the patients, the final consumer? 5: Research objective To identify the challenges in the pharmaceutical outbound value chains in Nigeria that limit the effectiveness of pharmaceutical organizations’ strategies of delivering medicines and other pharmaceutical products to the patients, the final consumer. 6: Research methodology A questionnaire of one closed-ended question (as earlier illustrated under the Delphi study) containing six sub-questions/latent variables was administered to 133 respondents from 64 organizations drawn from both sectors (private 4 Author name / Procedia Manufacturing 00 (2019) 000–000 and public). All seven categories (multinational manufacturing, overseas’ manufacturers’ representatives, indigenous manufacturers, importers/distributors, large pharmacy chains, State and Local government pharmaceutical services) of the pharmaceutical industry in Nigeria were sampled using a cross-sectional non-probability sampling technique. Responses were rated on a Likert scale of 1 – 5 according to the level of agreement and criticality of the measure variable. 103 questionnaires were completed, out of which 100 were valid, representing 77% response rate. The results of the responses were analysed with the statistical software, SPSS version 25 using descriptive, inferential and exploratory factor analysis (EFA) statistics. 7: Results In this section, the results of the responses for the challenges of the outbound pharmaceutical supply chains are presented. The items descriptive statistics (mean item scores, with their ranking) as well as the results for the exploratory factor analysis (EFA) using principal component analysis (PCA) are presented. Prior to the commencement of the analyses, a comprehensive definition of all the latent variables was done and the results are also provided. Table 1 shows the dictionary of definition of the latent variables used in question number 9 of the questionnaire. Table 1: Definition of latent variables Code Variable Name Definition Q1.1 Road Infrastructure The condition and adequacy of road network in the country Q1.2 Power Infrastructure The state, regularity and adequacy of the electricity power supply in the country Q1.3 Inadequate Policy & Regulation The insufficiency and ineffectiveness in the various laws and policies governing the pharmaceutical supply chains in the country Q1.4 Absence of competent 3PSPs Lack of reliable and competent third party organizations to manage the outbound pharmaceutical supply chains if outsourced to them Q1.5 Lack of skilled personnel Dearth of trained professionals to manage pharmaceutical supply chains Q1.6 Pilferages along the chain In-transit theft of products along the outbound pharmaceutical supply chains Table 2: Results mean item descriptives and ranking Latent Variables Mean Cronbach’s Alpha Ranking Road Infrastructure 4.09 0.739 1 Power Infrastructure 3.65 0.757 2 Inadequate Policy & Regulation 3.63 0.699 3 Absence of competent 3PSP 2.97 0.665 4 Lack of skilled personnel 3.06 0.673 5 Pilferages along the chain 2.88 0.707 6 Table 2 shows the results of the mean items descriptives of the variables and ranking of the challenges according to levels of criticality. It shows the mean and median item scores for the latent variables and their ranking. The ranking shows road infrastructure as the number 1 in the ranking, while power infrastructure is number 2, Absence of competent 3PL Service Providers is number 3, while Inadequate Policy & Regulation is ranked number 4. Lack of skilled personnel and Pilferages along the chain were ranked 5 and 6 respectively. Further data analysis using exploratory factor analysis (EFA) was conducted. Prior to this, the suitability and adequacy of the data for the analysis was determined. The correlation matrix showed many coefficient values of more than 0.30, showing a strong correlation between the factors. The internal reliability of the scale and composite scores was adequate with the Cronbach’s Alpha value of 0.745, above the recommended minimum value of 0.6, thus supporting

Solomon Aigbavboa et al. / Procedia Manufacturing 43 (2020) 336–343 339 Author name / Procedia Manufacturing 00 (2019) 000–000 3 Corruption The efficiency of healthcare delivery in any country is dependent on the judicious use of both human and financial resources to serve the sick population [16]. Corruption a big threat all aspects of national development. At a rank of 136 out of 176 by 2014; Nigeria is classified as one of the most corrupt nations in the world [17]. According to Transparency International, “corruption is everywhere: even the health and medical services, considered the least corrupt government institution, are considered very corrupt by 41 per cent of Nigerians”. In 2016, the Global Fund for the control of HIV/AIDs in Nigeria found widespread of corruption involving program funds running into millions of US Dollars [18]. Infrastructure Poor infrastructure has been identified as one of the significant structural barriers in the health systems of sub Saharan African countries [19]. In comparison with other economies like the middle- and high-income countries, Nigeria has one of the least-developed road networks with approximately 200 metres of roads per km2 pared compared to 1400 metres in high-income countries [20]. The supply chains of pharmaceuticals require steady, uninterrupted electricity for the storage and potency of thermolabile products like vaccines and antibiotics. The absence of a stable source of power also negatively affects certain aspects of the pharmaceutical supply chains especially the cold chains [21]. Weak regulatory systems Weak regulatory systems in many SSA impact negatively on the pharmaceutical supply chains. This is not only a challenge in itself, it also gives rise to a critical problem of poor quality medicines in the pharmaceutical supply chains. As high as 90% of national drug regulatory bodies in SSA are unable to effectively discharge their basic regulatory functions [22]. 3: Research gaps Many studies have been conducted on the Nigerian pharmaceutical industry but few on the supply chains and little or none on the challenges into the outbound value chains. Although the study by Isola & Mesagan [23] provided insights into the relationships and performance of the Nigerian pharmaceutical industry, it did not address the issues of supply chains in the industries. Findings from other studies have highlighted factors such as limited access to drugs [24, 25, 26] and fake drugs syndrome [15] as challenges associated with the pharmaceutical supply chains in Nigeria. Sieverding and Beyeler [8] undertook an extensive study on some channel players along chains. There exists no holistic empirical study on the challenges of both sectors of the industry. Furthermore, most of the previous studies have focused on one of the two sectors in the industry. This study aims to fill these research gaps. 4: Research question What are the challenges facing outbound pharmaceutical value chains in Nigeria. What problems limit the effectiveness of pharmaceutical organizations’ strategies of delivering medicines and other pharmaceutical products to the patients, the final consumer? 5: Research objective To identify the challenges in the pharmaceutical outbound value chains in Nigeria that limit the effectiveness of pharmaceutical organizations’ strategies of delivering medicines and other pharmaceutical products to the patients, the final consumer. 6: Research methodology A questionnaire of one closed-ended question (as earlier illustrated under the Delphi study) containing six sub-questions/latent variables was administered to 133 respondents from 64 organizations drawn from both sectors (private 4 Author name / Procedia Manufacturing 00 (2019) 000–000 and public). All seven categories (multinational manufacturing, overseas’ manufacturers’ representatives, indigenous manufacturers, importers/distributors, large pharmacy chains, State and Local government pharmaceutical services) of the pharmaceutical industry in Nigeria were sampled using a cross-sectional non-probability sampling technique. Responses were rated on a Likert scale of 1 – 5 according to the level of agreement and criticality of the measure variable. 103 questionnaires were completed, out of which 100 were valid, representing 77% response rate. The results of the responses were analysed with the statistical software, SPSS version 25 using descriptive, inferential and exploratory factor analysis (EFA) statistics. 7: Results In this section, the results of the responses for the challenges of the outbound pharmaceutical supply chains are presented. The items descriptive statistics (mean item scores, with their ranking) as well as the results for the exploratory factor analysis (EFA) using principal component analysis (PCA) are presented. Prior to the commencement of the analyses, a comprehensive definition of all the latent variables was done and the results are also provided. Table 1 shows the dictionary of definition of the latent variables used in question number 9 of the questionnaire. Table 1: Definition of latent variables Code Variable Name Definition Q1.1 Road Infrastructure The condition and adequacy of road network in the country Q1.2 Power Infrastructure The state, regularity and adequacy of the electricity power supply in the country Q1.3 Inadequate Policy & Regulation The insufficiency and ineffectiveness in the various laws and policies governing the pharmaceutical supply chains in the country Q1.4 Absence of competent 3PSPs Lack of reliable and competent third party organizations to manage the outbound pharmaceutical supply chains if outsourced to them Q1.5 Lack of skilled personnel Dearth of trained professionals to manage pharmaceutical supply chains Q1.6 Pilferages along the chain In-transit theft of products along the outbound pharmaceutical supply chains Table 2: Results mean item descriptives and ranking Latent Variables Mean Cronbach’s Alpha Ranking Road Infrastructure 4.09 0.739 1 Power Infrastructure 3.65 0.757 2 Inadequate Policy & Regulation 3.63 0.699 3 Absence of competent 3PSP 2.97 0.665 4 Lack of skilled personnel 3.06 0.673 5 Pilferages along the chain 2.88 0.707 6 Table 2 shows the results of the mean items descriptives of the variables and ranking of the challenges according to levels of criticality. It shows the mean and median item scores for the latent variables and their ranking. The ranking shows road infrastructure as the number 1 in the ranking, while power infrastructure is number 2, Absence of competent 3PL Service Providers is number 3, while Inadequate Policy & Regulation is ranked number 4. Lack of skilled personnel and Pilferages along the chain were ranked 5 and 6 respectively. Further data analysis using exploratory factor analysis (EFA) was conducted. Prior to this, the suitability and adequacy of the data for the analysis was determined. The correlation matrix showed many coefficient values of more than 0.30, showing a strong correlation between the factors. The internal reliability of the scale and composite scores was adequate with the Cronbach’s Alpha value of 0.745, above the recommended minimum value of 0.6, thus supporting

340 Solomon Aigbavboa et al. / Procedia Manufacturing 43 (2020) 336–343 Author name / Procedia Manufacturing 00 (2019) 000–000 5 the factorability of the data. The results for the factor analysis are presented in Tables 3 to 5. Table 3: Total Variance Explained Component Initial Eigenvalues Extraction Sums of Squared Loadings Rotation Sums of Squared Loadings Total % of Variance Cumulative % Total % of Variance Cumulative % Total % of Variance Cumulative % 1 2.726 45.438 45.438 2.726 45.438 45.438 2.388 39.8 39.8 2 1.556 25.937 71.375 1.556 25.937 71.375 1.894 31.575 71.375 3 0.587 9.777 81.152 4 0.49 8.161 89.313 5 0.357 5.947 95.26 6 0.284 4.74 100 Extraction Method: Principal Axis factoring. In Table 3, the factor analysis was with principal axis factoring with oblimin rotation. Two (2) factors with eigenvalue of more than 1 were extracted. The 2 factors extracted accounted for 71.4% of the total variance explained. Factor 1 accounted for 39.8% while Factor 2 accounted for 31.6% of the total variance explained. Table 4: Communalities Latent Variables Initial Extraction Road Infrastructure 1 0.687 Power Infrastructure 1 0.716 Inadequate Policy & Regulation 1 0.583 Absence of competent 3PSPs 1 0.733 Lack of skilled personnel 1 0.803 Pilferages along the chain 1 0.76 Table 5: Rotated component Matrix Latent Variables Component 1 2 Lack of skilled personnel 0.894 Pilferages along the chain 0.872 Absence of competent 3PSPs 0.817 Power Infrastructure 0.845 Road Infrastructure 0.826 Inadequate Policy & Regulation 0.655 The rotated component matrix shown in Table 5 shows the factors are comprised of three latent variables each. Factor 1 contains “lack of skilled personnel, pilferages along the chain and absence of competent 3rd Party Service Providers” while Factor 2 contains “power infrastructure, road infrastructure and inadequate policy/regulation”. From the relationships between these variables listed above, Factor 1 was termed People & competency issues while Factor 2 was called infrastructural & regulatory inadequacies 6 Author name / Procedia Manufacturing 00 (2019) 000–000 8: Discussions Factor 1 – People & competency issues The first factor of challenges to OPVC and its outsourcing in Nigeria is related to people issues. This factor, “people & competency issues” contains three latent variables – Lack of skilled personnel, pilferages along the chain and absence of competent 3rd Party Service Providers. Underlining every organization’s quest to undertake the strategic outsourcing of its OPVC is the desire to leverage on the specialized skills and knowledge of the 3PL service provider. [27]. This skill-set and competencies are different from those deployed in traditional, tactical outsourcing [28]. Studies have shown that these skills are a valuable source of competitive advantage for the outsourcing organization [29, 30] as the 3PL service provider’s expertise, managerial capabilities and competency are embedded in the knowledge and skill-set of its people (employees) deployed to manage the outsourced functions [31] . Lack of skills both in the outsourcing organization and the potential service provide is a critical challenge to the overall outsourcing process. The skill gaps identified among the human resources of the outsourcing organization manifest as inability to evaluate and or manage the outsourced functions [32]. Relationship management skills are also required during the tenure of the relationship. Pilferages along the value chain speaks of both process monitoring gap and sometimes, the integrity of the personnel involved in the handling of these products. Even though both the outsourcing organizations and their service providers have mitigating plans like stock and goods in transit insurance policies to indemnify them against financial losses resulting from these unwholesome practices, the negative impact of non-availability of the medicine to treat the target customer (sick patient) is a worrisome of treatment failures in the healthcare delivery system. Absence of competent 3PL service providers as a challenge to outbound pharmaceutical supply chains in Nigeria is closely related to the Infrastructural, industrial and economic development of the country. The 3PL Industry in Nigeria is still underdeveloped and dominated by some of the competent 3PL service providers like DHL & UPS who are multinational companies. The industry is very fragmented with many small privately-owned firms playing most in other sectors like Fast Moving Consumer Goods (FMCG) and Telecoms, where the regulations and requirements are not as stringent as those obtainable in the Pharmaceutical sector. Other organized players like MDS Logistics (a partnership between UAC of Nigeria & Imperial Logistics of South Africa) are also prominent in the sector and in the last decade have been serving the sector. There is still however a gap of scale and competence in the 3PL sector in Nigeria. Factor 2 – Infrastructural & regulatory inadequacies This factor contains exogenous barriers and challenges facing the outbound pharmaceutical value chains and their outsourcing not just in Nigeria but across the sub-Saharan and other developing countries with poor infrastructure and regulatory structures. The latent variables in this factor – Power Infrastructure, road Infrastructure and inadequate Policy & Regulation have over the years impacted negatively on both the costs and efficiency of the value chains. Pharmaceutical products are not just thermolabile and requiring special handling techniques, the facilities deployed in their management have high asset intensity, reflecting the ratio of the fixed asset to current assets involved [33]. Power supply is a very critical requirement for the handling of these products. From production to delivery to the final customer in the outbound value chain, steady and adequate power is very important in this highly-regulated sector. Nigeria like some most other sub-Saharan African countries still struggles with steady and adequate power supply. At power national power output of 5,000 megawatts for its 180million citizens compared to South Africa, another African economy with an output of about 53,000 megawatts for its 57 million citizens, Nigeria is obviously “underpowered” with corresponding negative consequences to the industries generally and power-intensive sectors like the pharmaceutical in particular. This is particularly worrisome in the supply chains of pharmaceuticals where steady, uninterrupted electricity is required for the storage and potency of thermolabile products like vaccines and antibiotics. The absence of a stable source of power also negatively affects certain aspects of the pharmaceutical supply chains especially the cold chains [21]. Nigeria has a very poorly developed and maintained road infrastructure, compared to middle- and high-income countries. Nigeria and other sub-Saharan countries on the average have a road

Solomon Aigbavboa et al. / Procedia Manufacturing 43 (2020) 336–343 341 Author name / Procedia Manufacturing 00 (2019) 000–000 5 the factorability of the data. The results for the factor analysis are presented in Tables 3 to 5. Table 3: Total Variance Explained Component Initial Eigenvalues Extraction Sums of Squared Loadings Rotation Sums of Squared Loadings Total % of Variance Cumulative % Total % of Variance Cumulative % Total % of Variance Cumulative % 1 2.726 45.438 45.438 2.726 45.438 45.438 2.388 39.8 39.8 2 1.556 25.937 71.375 1.556 25.937 71.375 1.894 31.575 71.375 3 0.587 9.777 81.152 4 0.49 8.161 89.313 5 0.357 5.947 95.26 6 0.284 4.74 100 Extraction Method: Principal Axis factoring. In Table 3, the factor analysis was with principal axis factoring with oblimin rotation. Two (2) factors with eigenvalue of more than 1 were extracted. The 2 factors extracted accounted for 71.4% of the total variance explained. Factor 1 accounted for 39.8% while Factor 2 accounted for 31.6% of the total variance explained. Table 4: Communalities Latent Variables Initial Extraction Road Infrastructure 1 0.687 Power Infrastructure 1 0.716 Inadequate Policy & Regulation 1 0.583 Absence of competent 3PSPs 1 0.733 Lack of skilled personnel 1 0.803 Pilferages along the chain 1 0.76 Table 5: Rotated component Matrix Latent Variables Component 1 2 Lack of skilled personnel 0.894 Pilferages along the chain 0.872 Absence of competent 3PSPs 0.817 Power Infrastructure 0.845 Road Infrastructure 0.826 Inadequate Policy & Regulation 0.655 The rotated component matrix shown in Table 5 shows the factors are comprised of three latent variables each. Factor 1 contains “lack of skilled personnel, pilferages along the chain and absence of competent 3rd Party Service Providers” while Factor 2 contains “power infrastructure, road infrastructure and inadequate policy/regulation”. From the relationships between these variables listed above, Factor 1 was termed People & competency issues while Factor 2 was called infrastructural & regulatory inadequacies 6 Author name / Procedia Manufacturing 00 (2019) 000–000 8: Discussions Factor 1 – People & competency issues The first factor of challenges to OPVC and its outsourcing in Nigeria is related to people issues. This factor, “people & competency issues” contains three latent variables – Lack of skilled personnel, pilferages along the chain and absence of competent 3rd Party Service Providers. Underlining every organization’s quest to undertake the strategic outsourcing of its OPVC is the desire to leverage on the specialized skills and knowledge of the 3PL service provider. [27]. This skill-set and competencies are different from those deployed in traditional, tactical outsourcing [28]. Studies have shown that these skills are a valuable source of competitive advantage for the outsourcing organization [29, 30] as the 3PL service provider’s expertise, managerial capabilities and competency are embedded in the knowledge and skill-set of its people (employees) deployed to manage the outsourced functions [31] . Lack of skills both in the outsourcing organization and the potential service provide is a critical challenge to the overall outsourcing process. The skill gaps identified among the human resources of the outsourcing organization manifest as inability to evaluate and or manage the outsourced functions [32]. Relationship management skills are also required during the tenure of the relationship. Pilferages along the value chain speaks of both process monitoring gap and sometimes, the integrity of the personnel involved in the handling of these products. Even though both the outsourcing organizations and their service providers have mitigating plans like stock and goods in transit insurance policies to indemnify them against financial losses resulting from these unwholesome practices, the negative impact of non-availability of the medicine to treat the target customer (sick patient) is a worrisome of treatment failures in the healthcare delivery system. Absence of competent 3PL service providers as a challenge to outbound pharmaceutical supply chains in Nigeria is closely related to the Infrastructural, industrial and economic development of the country. The 3PL Industry in Nigeria is still underdeveloped and dominated by some of the competent 3PL service providers like DHL & UPS who are multinational companies. The industry is very fragmented with many small privately-owned firms playing most in other sectors like Fast Moving Consumer Goods (FMCG) and Telecoms, where the regulations and requirements are not as stringent as those obtainable in the Pharmaceutical sector. Other organized players like MDS Logistics (a partnership between UAC of Nigeria & Imperial Logistics of South Africa) are also prominent in the sector and in the last decade have been serving the sector. There is still however a gap of scale and competence in the 3PL sector in Nigeria. Factor 2 – Infrastructural & regulatory inadequacies This factor contains exogenous barriers and challenges facing the outbound pharmaceutical value chains and their outsourcing not just in Nigeria but across the sub-Saharan and other developing countries with poor infrastructure and regulatory structures. The latent variables in this factor – Power Infrastructure, road Infrastructure and inadequate Policy & Regulation have over the years impacted negatively on both the costs and efficiency of the value chains. Pharmaceutical products are not just thermolabile and requiring special handling techniques, the facilities deployed in their management have high asset intensity, reflecting the ratio of the fixed asset to current assets involved [33]. Power supply is a very critical requirement for the handling of these products. From production to delivery to the final customer in the outbound value chain, steady and adequate power is very important in this highly-regulated sector. Nigeria like some most other sub-Saharan African countries still struggles with steady and adequate power supply. At power national power output of 5,000 megawatts for its 180million citizens compared to South Africa, another African economy with an output of about 53,000 megawatts for its 57 million citizens, Nigeria is obviously “underpowered” with corresponding negative consequences to the industries generally and power-intensive sectors like the pharmaceutical in particular. This is particularly worrisome in the supply chains of pharmaceuticals where steady, uninterrupted electricity is required for the storage and potency of thermolabile products like vaccines and antibiotics. The absence of a stable source of power also negatively affects certain aspects of the pharmaceutical supply chains especially the cold chains [21]. Nigeria has a very poorly developed and maintained road infrastructure, compared to middle- and high-income countries. Nigeria and other sub-Saharan countries on the average have a road

342 Solomon Aigbavboa et al. / Procedia Manufacturing 43 (2020) 336–343 Author name / Procedia Manufacturing 00 (2019) 000–000 7 density of only approximately 200 metres of paved roads per square kilometres compared to 1400 metres in high-income countries [20]. Good road infrastructure is needed to accelerate enhance the management of the outbound pharmaceutical value chains and the socio-economic development of the country. Notwithstanding the efforts made and the various economic developmental strides and growth that have been recorded by the country, persistent infrastructure deficits still pose a number of challenges [34]. This infrastructural deficit has been acknowledged as a challenge to the management of OPVC and one of the most substantial structural barriers in the health systems of the country [19, 35]. Delivering pharmaceutical products across these decrepit and sometimes, almost impossible to navigate roads, over hundreds of kilometre is an exogenous one which, far beyond the purview and control of the pharmaceutical companies continues to impact negatively on the efficiency of their outbound value chains. Included in this factor is another external challenge – that of inadequate policy/regulation and absence of competent 3PL service providers. The pharmaceutical sector is one of the most regulated sectors in any country, Nigeria inclusive, on account of the object (drugs) and subject (human) of the products. The most stringent requirements and standards are imposed on the processes and organizations associated with the handling of these products from production to delivery to the final customer, a patient. Despite the foregoing, a lot of lapses exist in the regulatory framework of the sector. From policy formation and/or enforcement of existing policies and laws, gaps exist, which have been capitalized by unscrupulous elements who make merchandize of the system for their selfish, financial gains. In Nigeria and some other sub-Saharan African countries, Weak regulatory structure impact negatively on the pharmaceutical supply chains. Several of these national regulatory bodies and agencies (like the National Agency for Food, Drug Administration & Control, NAFDAC in Nigeria) in these countries lack adequate resources needed to control the origin and inflow of medicines being pushed into the outbound supply chains [36]. This is not only a challenge in itself, it also gives rise to a critical problem of poor quality medicines in the pharmaceutical supply chains [22]. It has been reported that as high as 90% of national drug regulatory bodies in SSA are unable to effectively discharge their basic regulatory functions [22]. 9: Conclusion and recommendations The supply chains of the pharmaceutical industry in Nigeria and most sub-Saharan African countries underperform. Yadav [2] and other researchers have provided an overview of the root causes for this underperformance. This study has provided more insight from an empirical perspectives with the participation of the industry players in both the public and private sectors. Most of the challenges identified and investigated in this study relate to the critical issues of people, expertise and the state of infrastructure and regulatory framework of the country. Whilst some of these issues are internal to the organizations and can be easily addressed with specific case-related solutions and strategies, others are external and in some instances somewhat related to the public sector governance policies and framework in the country. Reforms, continuous upgrade and improvement of the entire healthcare and pharmaceutical system and policy is required to effectively tackle these challenges. Furthermore, a multi-stakeholders’ approach involving policy makers from both public/private sectors and financial institutions (for industry-specific funding solutions) is recommended. References [1] Kraiselburd, S. Yadav, P. Supply chains and global health: an imperative for bringing operations management scholarship into action. Production & Operations Management. 22 (2013) 377 – 381 [2]. Yadav, P. Health Product Supply Chains in Developing Countries: Diagnosis of the Root Causes of Underperformance and an Agenda for Reform. Health Systems & Reform 1. (2015) 142-154 [3] Jaberidoost, M. Nikfar, S. Abdollahiasl, A. Dinarvand, R. Pharmaceutical supply chain risks: a systematic review. DARU Journal of Pharmaceutical Sciences. 12 (2013) 69 – 82. [4] Kohler, J. Pavignani, E. Michael, M. Ovtcharenko, N. Murru, M.Hill, P. An examination of pharmaceutical systems in severely disrupted countries. BMC International Health and Human Rights. 12 ((2012) 1 – 13 [5]. Yousefi, N. Alibabaei, A. Information Flow in the Pharmaceutical Supply Chain. Iranian Journal of Pharmaceutical Research. 14 ((2015) 1299-1303 [6] Iyengar, S. Hedman, L. Forte, G. Hill, S. Medicine shortages: a commentary on causes and mitigation strategies. BMC Medicine. 14 (2016).1-3 8 Author name / Procedia Manufacturing 00 (2019) 000–000 [7] Oyekale, S. A. Assessment of primary health care facilities’ service readiness in Nigeria. BMC Health Services Research. 17 (2017). 1 – 12 [8] Sieverding, M. Beyeler, N. Integrating informal providers into a people-centred health systems approach: qualitative evidence from local health systems in rural Nigeria. BMC Health Services Research. 16 (2016). 1 -12. [9] Khan, A.N. Khar, R.K. Current Scenario of Spurious and Substandard Medicines in India: A Systematic Review. Indian Journal of Pharmaceutical Sciences. 77 (2015). 2–7 [10] Sayed, Z. Sunjka, B.P. Investigating and evaluating the influence of supply chain structure on supply chain risk. South African Journal of Industrial Engineering 27 (2016). 122-135 [11] Zegordi, S. Davarzani, H.. Developing a supply chain disruption analysis model: Application of colored Petri-nets. Expert Systems with Applications. 39 (2012) 2102-2111 [12] Hamisu, A.W. Johnson, T.M. Craig, K. Mkanda, P. Banda, R. Tegegne, S.G. Oyetunji, A. Ningi, N. Mohammed, S. Adamu, M.I. Abdulrahim, K. Nsubuga, P. Vaz, R.G. Muhammed, A.J.. Strategies for Improving Polio Surveillance Performance in the Security-Challenged Nigerian States of Adamawa, Borno and Yobe During 2009 – 2014. Journal of Infectious Diseases. 213 (2016) 136-139 [13] Sauls, C. Trend in revenue loss due to expired medication at a large urban hospital in Johannesburg, South Africa. (2016). Unpublished MPH Thesis, University of the Witwatersrand; South Africa. [14] Olatunji, O.E. The Politics of Pharmaceutical Regulation in Nigeria: Policy options for Third World Countries. Public Policy and Administration Research. Vol. 3 (2013). 89 – 102. [15] Oluwatuyi, O. Ileri, O.N. Fake Drugs Syndrome and Implications on National Development. Research Journal in Organizational Psychology & Educational Studies. . 3 (2014). 393 – 402 [16] Tormusa, D.O.Idom, A.M. The Impediments of Corruption on the Efficiency of Healthcare Service Delivery in Nigeria. Online Journal of Health Ethics. 12 (2016). 1 – 13 [17] Transparency International. Nigeria’s corruption challenge. (2015) Retrieved from http://www.transparency.org/news/feature/nigerias_corruption_challenge.). [18] Global Fund. Investigation Report of Global Fund Grants to Nigeria. Department of Health Planning, Research & Statistics GF-OIG-16-015. Geneva, Switzerland (2016). Available at http://www.theglobalfund.org [19] Fowkes, F.J. Draper, B.L. Hellard, M. Stoové, M. Achieving development goals for HIV, tuberculosis and malaria in sub-Saharan Africa through integrated antenatal care: barriers and challenges. BMC Medicine. 14 (2016).1-10. [20] Schürenberg-Frosch, H. Improving Africa’s Roads: Modelling Infrastructure Investment and Its Effect on Sectoral Production Behaviour. Development Policy Review. 32 (2014). 327–353 [21] Yakum, M. Ateudjieu, J. Pélagie, F. Walter, E. Watcho, P. Factors associated with the exposure of vaccines to adverse temperature conditions: the case of North West region, Cameroon. BMC Research Notes. 8 (2015). 1 – 7 [22] Giralt, A. Schiavetti, B. Meessen, B. Pouget, C; Caudron, J. Marchal, B. Massat, P. Thys, S. Ravinetto, S. Quality assurance of medicines supplied to low-income and middle-income countries: poor products in shiny boxes? BMJ Global Health. 2 (2017) 1 – 11 [23] Isola, W. A. Mesagan, E. P. Determinants of Pharmaceutical Industry’s Performance in Nigeria. Managing Global Transitions. 14 (2016) 267 – 282 [24] Adebisi, A. O. Access to antiretroviral drugs in rural communities in Nigeria. MPH thesis, Graduate school of biomedical sciences, Icahn School of medicine at Mount Sinai. (2013) [25] Obuaku, C. Essential Medicines in Nigeria: Foregrounding Access to Affordable Essential Medicines. African Sociological Review. (2014). 41 – 60. [26] Onwuka, C. The relationship between access to medicine and transformational leadership in Nigeria. Ph.D. Thesis, Capella University. (2016). [27] Zhang, M. Pawar, K.S. Shah, J. Mehta, P. Evaluating outsourcing partners’ capability: a case study from the pharmaceutical supply chain. Journal of Manufacturing Technology Management. 24 (2013).1080-1101 [28] Ordoobadi, S.M. Development of a supplier selection model using fuzzy logic. Supply Chain Management: An International Journal. 14 (2009). 314-327. [29] Ketchen, D.J. Hult, G.T.M. Bridging organization theory and supply chain management: the case of best value supply chains. Journal of Operations Management. 25 (2007) 573-580. [30] Brewer, B; Ashenbaum, B. Ogden, J. A. Connecting strategy-linked outsourcing approaches and expected performance. International Journal of Physical Distribution & Logistics Management. 43 (2013) 176 – 204 [31] Bhattacharya, A. Singh, P.J. Bhakoo, V. Revisiting the outsourcing debate: two sides of the same story. Production Planning & Control. 24 (2013). 399-422 [32] El Mokrini, A. Dafaoui, E. Berrado, A. El Mhamedi, A. An approach to risk Assessment for Outsourcing Logistics: Case of Pharmaceutical Industry IFAC-PapersOnLine 49-12 (2016). IFAC Conference on Manufacturing Modelling, Management and Control June 28-30, 2016. Troyes, France. [33] Hofmann, E. Lampe, K. Financial statement analysis of logistics service providers: ways of enhancing performance. International Journal of Physical Distribution & Logistics Management. 43 (2013). 321-342 [34] Arewa, O. Constructing Africa: Chinese Investment, Infrastructure Deficits and Development. Cornell International Law Journal. 49 (2016). 101 – 140 [35] Ettah, L (2017). Press Conference on: Nigerian Macroeconomic Review. March 9, 2017. Lagos, Nigeria [36] Preston, C. Valdez, M. L. Bond, K. Strengthening medical product regulation in low- and middle-income countries. PLoS Med. Vol. 9 (2012) 1 – 3

Solomon Aigbavboa et al. / Procedia Manufacturing 43 (2020) 336–343 343 Author name / Procedia Manufacturing 00 (2019) 000–000 7 density of only approximately 200 metres of paved roads per square kilometres compared to 1400 metres in high-income countries [20]. Good road infrastructure is needed to accelerate enhance the management of the outbound pharmaceutical value chains and the socio-economic development of the country. Notwithstanding the efforts made and the various economic developmental strides and growth that have been recorded by the country, persistent infrastructure deficits still pose a number of challenges [34]. This infrastructural deficit has been acknowledged as a challenge to the management of OPVC and one of the most substantial structural barriers in the health systems of the country [19, 35]. Delivering pharmaceutical products across these decrepit and sometimes, almost impossible to navigate roads, over hundreds of kilometre is an exogenous one which, far beyond the purview and control of the pharmaceutical companies continues to impact negatively on the efficiency of their outbound value chains. Included in this factor is another external challenge – that of inadequate policy/regulation and absence of competent 3PL service providers. The pharmaceutical sector is one of the most regulated sectors in any country, Nigeria inclusive, on account of the object (drugs) and subject (human) of the products. The most stringent requirements and standards are imposed on the processes and organizations associated with the handling of these products from production to delivery to the final customer, a patient. Despite the foregoing, a lot of lapses exist in the regulatory framework of the sector. From policy formation and/or enforcement of existing policies and laws, gaps exist, which have been capitalized by unscrupulous elements who make merchandize of the system for their selfish, financial gains. In Nigeria and some other sub-Saharan African countries, Weak regulatory structure impact negatively on the pharmaceutical supply chains. Several of these national regulatory bodies and agencies (like the National Agency for Food, Drug Administration & Control, NAFDAC in Nigeria) in these countries lack adequate resources needed to control the origin and inflow of medicines being pushed into the outbound supply chains [36]. This is not only a challenge in itself, it also gives rise to a critical problem of poor quality medicines in the pharmaceutical supply chains [22]. It has been reported that as high as 90% of national drug regulatory bodies in SSA are unable to effectively discharge their basic regulatory functions [22]. 9: Conclusion and recommendations The supply chains of the pharmaceutical industry in Nigeria and most sub-Saharan African countries underperform. Yadav [2] and other researchers have provided an overview of the root causes for this underperformance. This study has provided more insight from an empirical perspectives with the participation of the industry players in both the public and private sectors. Most of the challenges identified and investigated in this study relate to the critical issues of people, expertise and the state of infrastructure and regulatory framework of the country. Whilst some of these issues are internal to the organizations and can be easily addressed with specific case-related solutions and strategies, others are external and in some instances somewhat related to the public sector governance policies and framework in the country. Reforms, continuous upgrade and improvement of the entire healthcare and pharmaceutical system and policy is required to effectively tackle these challenges. Furthermore, a multi-stakeholders’ approach involving policy makers from both public/private sectors and financial institutions (for industry-specific funding solutions) is recommended. References [1] Kraiselburd, S. Yadav, P. Supply chains and global health: an imperative for bringing operations management scholarship into action. Production & Operations Management. 22 (2013) 377 – 381 [2]. Yadav, P. Health Product Supply Chains in Developing Countries: Diagnosis of the Root Causes of Underperformance and an Agenda for Reform. Health Systems & Reform 1. (2015) 142-154 [3] Jaberidoost, M. Nikfar, S. Abdollahiasl, A. Dinarvand, R. Pharmaceutical supply chain risks: a systematic review. DARU Journal of Pharmaceutical Sciences. 12 (2013) 69 – 82. [4] Kohler, J. Pavignani, E. Michael, M. Ovtcharenko, N. Murru, M.Hill, P. An examination of pharmaceutical systems in severely disrupted countries. BMC International Health and Human Rights. 12 ((2012) 1 – 13 [5]. Yousefi, N. Alibabaei, A. Information Flow in the Pharmaceutical Supply Chain. Iranian Journal of Pharmaceutical Research. 14 ((2015) 1299-1303 [6] Iyengar, S. Hedman, L. Forte, G. Hill, S. Medicine shortages: a commentary on causes and mitigation strategies. BMC Medicine. 14 (2016).1-3 8 Author name / Procedia Manufacturing 00 (2019) 000–000 [7] Oyekale, S. A. Assessment of primary health care facilities’ service readiness in Nigeria. BMC Health Services Research. 17 (2017). 1 – 12 [8] Sieverding, M. Beyeler, N. Integrating informal providers into a people-centred health systems approach: qualitative evidence from local health systems in rural Nigeria. BMC Health Services Research. 16 (2016). 1 -12. [9] Khan, A.N. Khar, R.K. Current Scenario of Spurious and Substandard Medicines in India: A Systematic Review. Indian Journal of Pharmaceutical Sciences. 77 (2015). 2–7 [10] Sayed, Z. Sunjka, B.P. Investigating and evaluating the influence of supply chain structure on supply chain risk. South African Journal of Industrial Engineering 27 (2016). 122-135 [11] Zegordi, S. Davarzani, H.. Developing a supply chain disruption analysis model: Application of colored Petri-nets. Expert Systems with Applications. 39 (2012) 2102-2111 [12] Hamisu, A.W. Johnson, T.M. Craig, K. Mkanda, P. Banda, R. Tegegne, S.G. Oyetunji, A. Ningi, N. Mohammed, S. Adamu, M.I. Abdulrahim, K. Nsubuga, P. Vaz, R.G. Muhammed, A.J.. Strategies for Improving Polio Surveillance Performance in the Security-Challenged Nigerian States of Adamawa, Borno and Yobe During 2009 – 2014. Journal of Infectious Diseases. 213 (2016) 136-139 [13] Sauls, C. Trend in revenue loss due to expired medication at a large urban hospital in Johannesburg, South Africa. (2016). Unpublished MPH Thesis, University of the Witwatersrand; South Africa. [14] Olatunji, O.E. The Politics of Pharmaceutical Regulation in Nigeria: Policy options for Third World Countries. Public Policy and Administration Research. Vol. 3 (2013). 89 – 102. [15] Oluwatuyi, O. Ileri, O.N. Fake Drugs Syndrome and Implications on National Development. Research Journal in Organizational Psychology & Educational Studies. . 3 (2014). 393 – 402 [16] Tormusa, D.O.Idom, A.M. The Impediments of Corruption on the Efficiency of Healthcare Service Delivery in Nigeria. Online Journal of Health Ethics. 12 (2016). 1 – 13 [17] Transparency International. Nigeria’s corruption challenge. (2015) Retrieved from http://www.transparency.org/news/feature/nigerias_corruption_challenge.). [18] Global Fund. Investigation Report of Global Fund Grants to Nigeria. Department of Health Planning, Research & Statistics GF-OIG-16-015. Geneva, Switzerland (2016). Available at http://www.theglobalfund.org [19] Fowkes, F.J. Draper, B.L. Hellard, M. Stoové, M. Achieving development goals for HIV, tuberculosis and malaria in sub-Saharan Africa through integrated antenatal care: barriers and challenges. BMC Medicine. 14 (2016).1-10. [20] Schürenberg-Frosch, H. Improving Africa’s Roads: Modelling Infrastructure Investment and Its Effect on Sectoral Production Behaviour. Development Policy Review. 32 (2014). 327–353 [21] Yakum, M. Ateudjieu, J. Pélagie, F. Walter, E. Watcho, P. Factors associated with the exposure of vaccines to adverse temperature conditions: the case of North West region, Cameroon. BMC Research Notes. 8 (2015). 1 – 7 [22] Giralt, A. Schiavetti, B. Meessen, B. Pouget, C; Caudron, J. Marchal, B. Massat, P. Thys, S. Ravinetto, S. Quality assurance of medicines supplied to low-income and middle-income countries: poor products in shiny boxes? BMJ Global Health. 2 (2017) 1 – 11 [23] Isola, W. A. Mesagan, E. P. Determinants of Pharmaceutical Industry’s Performance in Nigeria. Managing Global Transitions. 14 (2016) 267 – 282 [24] Adebisi, A. O. Access to antiretroviral drugs in rural communities in Nigeria. MPH thesis, Graduate school of biomedical sciences, Icahn School of medicine at Mount Sinai. (2013) [25] Obuaku, C. Essential Medicines in Nigeria: Foregrounding Access to Affordable Essential Medicines. African Sociological Review. (2014). 41 – 60. [26] Onwuka, C. The relationship between access to medicine and transformational leadership in Nigeria. Ph.D. Thesis, Capella University. (2016). [27] Zhang, M. Pawar, K.S. Shah, J. Mehta, P. Evaluating outsourcing partners’ capability: a case study from the pharmaceutical supply chain. Journal of Manufacturing Technology Management. 24 (2013).1080-1101 [28] Ordoobadi, S.M. Development of a supplier selection model using fuzzy logic. Supply Chain Management: An International Journal. 14 (2009). 314-327. [29] Ketchen, D.J. Hult, G.T.M. Bridging organization theory and supply chain management: the case of best value supply chains. Journal of Operations Management. 25 (2007) 573-580. [30] Brewer, B; Ashenbaum, B. Ogden, J. A. Connecting strategy-linked outsourcing approaches and expected performance. International Journal of Physical Distribution & Logistics Management. 43 (2013) 176 – 204 [31] Bhattacharya, A. Singh, P.J. Bhakoo, V. Revisiting the outsourcing debate: two sides of the same story. Production Planning & Control. 24 (2013). 399-422 [32] El Mokrini, A. Dafaoui, E. Berrado, A. El Mhamedi, A. An approach to risk Assessment for Outsourcing Logistics: Case of Pharmaceutical Industry IFAC-PapersOnLine 49-12 (2016). IFAC Conference on Manufacturing Modelling, Management and Control June 28-30, 2016. Troyes, France. [33] Hofmann, E. Lampe, K. Financial statement analysis of logistics service providers: ways of enhancing performance. International Journal of Physical Distribution & Logistics Management. 43 (2013). 321-342 [34] Arewa, O. Constructing Africa: Chinese Investment, Infrastructure Deficits and Development. Cornell International Law Journal. 49 (2016). 101 – 140 [35] Ettah, L (2017). Press Conference on: Nigerian Macroeconomic Review. March 9, 2017. Lagos, Nigeria [36] Preston, C. Valdez, M. L. Bond, K. Strengthening medical product regulation in low- and middle-income countries. PLoS Med. Vol. 9 (2012) 1 – 3

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