Tuesday, 20 July 2021

Lupine Publishers| It Is Disturbing, In Spite of The Existence of Appropriate Legislation, Illegal Distribution of Medicines

 Lupine Publishers| LOJ Pharmacology & Clinical Research (LOJPCR)


Abstract

The strategy of price liberalisation and Privatization had been implemented in Sudan over the last decade and has had a positive result on government deficit. The investment law approved recently has good statements and rules on the above strategy in particular to pharmacy regulations. Under the pressure of the new privatization policy, the government introduced radical changes in the pharmacy regulations. To improve the effectiveness of the public pharmacy, resources should be switched towards areas of need, reducing inequalities and promoting better health conditions. Medicines are financed either through cost sharing or full private. The role of the private services is significant. A review of reform of financing medicines in Sudan is given in this study. Also, it highlights the current drug supply system in the public sector, which is currently responsibility of the Central Medical Supplies Public Corporation (CMS). In Sudan, the researchers did not identify any rigorous evaluations or quantitative studies about the impact of drug regulations on the quality of medicines and how to protect public health against counterfeit or low-quality medicines, although it is practically possible. However, the regulations must be continually evaluated to ensure the public health is protected against by marketing high quality medicines rather than commercial interests, and the drug companies are held accountable for their conduct.

Keywords: Counterfeits Medicines; Drug Importers; Quality of Medicines; Regulatory Authorities

Abbrevations:CMSPO: Central Medical Supplies Public Organization; CRC: Centre of Regulation and Competition; DAP: Drug Action Programme; DOP: Department of Pharmacy; FGDOP: Federal General Directorate of Pharmacy; FMOH: Federal Ministry of Health; FPPB: Federal Pharmacy and Poison Board; GMP: Good Manufacturing Practice; KS: Khartoum State; MOAR: Ministry of Animal Resources; MOH: Ministry of Health; NGOs: Non-Governmental Organizations; NDP: National Drug Policy; RDFs: Revolving Drug Funds; SPSS: Statistical Package for Social Sciences; UK: United Kingdom; USA: United States of America; WHO: World Health Organization.

Introduction

The World Health Organization [1] has defined drug regulation as a process, which encompasses various activities, aimed at promoting and protecting public health by ensuring the safety, efficiency and quality of drugs, and appropriateness accuracy of information [1]. Medicines regulation is a key instrument employed by many governments to modify the behaviour of drug systems. The regulation of pharmaceuticals relates to control of manufacturing standards, the quality, the efficacy and safety of drugs, labelling and information requirements, distribution procedures and consumer prices [2]. To assure quality of medicines, in most countries registration is required prior to the introduction of a drug preparation into the market. The manufacturing, registration and sale of drugs have been the subject of restricts regulations and administrative procedures worldwide for decades [3]. Nobody would seriously argue drugs should be proven to be 100% safe. No set of regulations could achieve that goal argue, because it is impossible, and all drugs carry some risk [4]. Stringent drug regulation was introduced across many countries in the 1960s following the thalidomide disaster and had since been embraced by the industry as a commercial essential seal of safety and quality [5]. In spite of the measures, many countries, especially developing one face a broader range of problems. In several developing countries drug quality is a source of concern. There is a general feeling of high incidence of drug preparations that are not of acceptable quality [6]. For example, about 70% of counterfeit medicines were reported by developing countries [7]. Reports from Asia, Africa, and South America indicate 10% to 50% of consider using prescribed drugs in certain countries may be counterfeit [8]. For instance, in Nigeria fake medicines may be more than 60 -70% of the drugs in circulation [9], and 109 children died in 1990 after being administered fake Paracetamol [10]. In Gambia the drug registration and control system resulted in the elimination of ‘drug peddlers’ and certain ‘obsolete and harmful’ drugs, as well as a large decrease in the percentage of brand and combination drugs [11]). The percentage of drugs failing quality control testing was found to be zero in Colombia, but 92% in the private sector of Chad [12]. Hence, it is very difficult to obtain accurate data. The proportion of counterfeit drugs in the USA marketplace is believed to be small - less than 1 percent [12]. In [13] reported two cases of counterfeit medicines that found their way into legitimate medicine supply chain in the UK in 2004.

Poor quality drug preparations may lead to adverse clinical results both in terms of low efficacy and in the development of drug resistance [14]. Regulations are the basic devices employed by most governments to protect the public health against substandard, counterfeit, low quality medicines, and to control prices. Thorough knowledge of whether these regulations produce the intended effects or generate unexpected adverse consequences is critical. The World Health Organization (WHO) undertook a number of initiatives to improve medicines quality in its member states and promote global mechanisms for regulating the quality of pharmaceutical products in the international markets. Yet, there are not any WHO guidelines on how to evaluate the impact of these regulations. There are numerous reports concerning drug regulations [15], but the published work on the impact of these regulations on the quality of medicines moving in the international commerce has been scarce. Findings from most published studies lack comparable quantitative information that would allow for objective judging whether and by how much progress on the various outcomes have been made by the implementation of the pharmaceutical regulations. To ignore evaluations and to implement drug regulation based on logic and theory is to expose society to untried measures in the same way patients were exposed to untested medicines [15]. The present policy of the national health-care system in Sudan is based on ensuring the welfare of the Sudanese inhabitants through increasing national production and upgrading the productivity of individuals. A health development strategy has been formulated in a way that realises the relevancy of health objectives to the main goals of the national development plans. The strategy of Sudan at the national level aims at developing the Primary Health Care (PHC) services in the rural areas as well as urban areas. In Sudan 2567 physicians provide the public health services (554 specialists, 107 medical registrars, 1544 medical officers, 156 dentists, and 206 pharmacists) [16]. Methods of preventing and controlling health problems are the following:

a) Promotion of food supply and proper nutrition

b) An adequate supply of safe water and basic sanitation;

c) Maternal and child health-care

d) Immunisation against major infectious diseases

e) Preventing and control of locally endemic diseases

f) Provision of essential drugs.

This will be achieved through a health system consisting of three levels (state, provincial and localities), including the referral system, secondary and tertiary levels. Pharmacy management should be coordinated and integrated with other various aspects of health. The following are recommended:

a. The community must be the focus of benefits accruing from restructures, the legislature should protect community interest on the basis of equity and distribution, handover the assets to the community should be examined; and communities shall encourage the transfer the management of health schemes to a professional entity.

b. The private sector should be used to mobilise and strengthen the technical and financial resources from within and outside the country to implement the services, with particular emphasis on utilisation of local resources.

c. The government should provide the necessary financial resources to guide the process of community management of pharmacy supplies. The government should be a facilitator through setting up standards, specifications and rules to help harmonise the private sector and establish a legal independent body by an act of parliament to monitor and control the providers. Government should assist the poor communities who cannot afford service cost and alleviate social-economic negative aspects of Privatization.

d. The sector actors should create awareness to the community of the roles of the private sector and government in the provision of health and pharmacy services.

e. Support agencies should assist with financial and technical support, training facilities, coordination, development and dissemination of health projects, as well as evaluation of projects.

Aims and Objectives

The main purpose of this study is to analyse and determine the opinion of a group of pharmacists who are the owners or shareholders in the Sudanese medicine importing companies and their perception concerning the effects of the government’s new Pharmacy, Poisons, Cosmetics and Medical Devices Act has had on the quality of medicines in Sudan. To achieve this purpose the following questions would be answered:

A. Do the Sudan pharmacy legislations prohibit marketing of low-quality medicines?

B. What is the impact of the transfer of veterinary medicines registration system to the Ministry of Animal Resources after the approval of the Pharmacy and Poisons Act 2001?

C. Does pre-marketing analysis of medicines help to detect the counterfeit medicines?

D. Does importation of non-registered medicines by the government and non- governmental organizations exacerbate the problem of low-quality medicine if any?

In Sudan, the researchers did not identify any rigorous evaluations or quantitative studies about the impact of drug regulations on the quality of medicines and how to protect public health against counterfeit or low-quality medicines, although it is practically possible. However, the regulations must be continually evaluated to ensure the public health is protected against fake medicines by ensuring the exclusive marketing of high-quality medicines rather than commercial interests, and the drug companies are held accountable for their conducts [17].

Medicines Legislation Framework in Sudan

The availability of medicines in Sudan is controlled on the basis of safety, quality and efficacy. Thus, the government effects control in accordance with the Pharmacy, Poisons, Cosmetics and Medical Devices Act 2001 and its instruments. The Federal or State Departments of Pharmacy (DOP) and directives issued orders. The primary objective of both Federal and States’ Departments of Pharmacy is to safeguard public health by ensuring all medicines and pharmaceuticals on the Sudan market meet appropriate standards of safety, quality and efficacy. The safeguarding of public health is achieved largely through the system of medicines’ registration and licensing of pharmacy premises. The first Pharmacy and Poisons Act was enacted in 1939. This Act had been amended three times since then. In 2001 amendments, cosmetics and medical devices were also brought under its purview. Thus, the name was changed to Pharmacy, Poisons, Cosmetics and Medical Devices Act (hereafter the Act). The Act regulates the compounding, sale, distribution, supply, dispensing of medicines and provides different levels of control for different categories, e.g., medicines, poisons, cosmetics, chemicals for medical use and medical devices. The Act makes provision for the publication of regulations and guidelines by the Federal Pharmacy and Poisons Board (FPPB), the pharmaceutical regulatory authority and its executive arm - the Federal General Directorate of Pharmacy (FGDOP). The FGDOP regulates mainly four aspects of medicines use: safety, quality, efficacy and price. Traditionally, governments in many countries, particularly developed nations have attempted to ensure the efficiency, safety, rational prescribing, and dispensing of drugs through pre-marketing registration, licensing and other regulatory requirements [18]. When applying to register the medicine manufacturers and importers are required to furnish the FGDOP with a dossier of information including among others, the indication of the medicine, its efficacy, side effects, contraindication, warnings on usage by high risk groups, price, storage and disposal [18]. The role of the FGDOP includes among others:

a) Regulation and control of the importation, exportation, manufacture, advertisement, distribution, sale and the use of medicines, cosmetics, medical devices and chemicals;

b) Approval and registration of new medicines - the Act requires FGDOP should register every medicine before be sold or marketed. Companies are required to submit applications for the registration of medicines for the evaluation and approval;

c) Undertake appropriate investigations into the production premises and raw materials for drugs and establish relevant quality assurance systems including certification of the production sites and regulated products;

d) Undertake inspection of drugs’ whole and retail sellers owned by both public or private sectors;

e) Compile standard specifications and regulations and guidelines for the production, importation, exportation, sale and distribution of drugs, cosmetics, etc.

f) Control of quality of medicines: This will be done by regular inspection and post-marketing surveillance;

g) Licensing of pharmacy premises (i.e., pharmaceutical plants, wholesalers and retail pharmacies);

h) Maintain national drug analysis laboratories for the preand post- marketing analysis of medicines;

i) Coordination with states departments of pharmacy to ensure the enforcement of the Act and its rules and directives.

Health and Pharmacy Systems:

The health system in Sudan is characterised by heavy reliance on charging users at the point of access (private expenditure on health is 79.1 percent), with less use of prepayment system such as health insurance. The way the health system is funded, organised, managed and regulated affects health workers’ supply, retention, and the performance. Primary Health Care was adopted as a main strategy for health-care provision in Sudan and new strategies were introduced during the last decade, including:

i. Health area system.

ii. Polio eradication in 1988.

iii. Integrated management of children illness (IMCI) initiative.

iv. Rollback malaria strategy

v. Basic developmental need approach in 1997.

vi. Safe motherhood, making pregnancy safer initiative, eradication of harmful traditional practices and emergency obstetrics’ care programmes.

The strategy of price liberalization and privatization had been implemented in Sudan over the last decades and has had a positive result on the government deficit. The investment law [19] approved recently has good statements and rules on the above strategy in particular to health and pharmacy areas. The privatization and price liberalization in healthy fields has to re-structure (but not fully). Availability and adequate pharmacy supply to the major sectors. The result is that the present situation of pharmacy services is far better than ten years ago. The government of Sudan has a great experience in privatization of the public institutions, i.e., the Sudanese free zones and markets, Sudan telecommunications (Sudatel) and Sudan airlines. These experiences provide good lessons about the efficiency and effectiveness of the privatization policy. Through privatization, the government is not evading its responsibility of providing health-care to the inhabitants, but merely shifting its role from being a provider to a regulator and standard setter. Drug financing was privatized early in 1992. Currently, the Federal Ministry of Health (FMOH) has privatized certain non-medical services in hospitals such as catering services, security and cleanings.

The overall goal of the CMS ownership privatization is to improve access to essential medicines and other medical supplies in order to improve health status of the inhabitants particularly in far states (e.g., Western and Southern States). Establishment of alternative ownership for the CMS can be achieved by selling the majority of shares to the private sector. This will achieve the following objectives:

a. High access to essential medicines of good quality and affordable prices to the states’ population and governments.

b. Efficiency and effectiveness in drug distribution system to avoid the serious pitfalls and incidences that was reported during the last ten years in the CMS.

c. Equity by reaching all remote areas currently deprived from the formal drug distribution channels.

d. Improvement of the quality and quantity of delivery of medicines to the public health facilities.

The above objectives are expected to:

a) Increase geographical and economic access to essential medicines in all states (i.e., in both rural and urban areas) to reach at least 80% of the population (currently less than 50% of population have access to essential medicines).

b) The tax collection from the new business becomes more efficient and will increase after privatization. The tax revenues could be used to finance other health-care activities.

c) If the government reserves some shares (not more than 50%) in the new business, then its shares’ profit could be used to finance free medicines project in hospitals outpatients’ clinic, and other exempted medicines, e.g., renal dialysis and hemophilic patients’ treatment.

Privatization of Public Pharmaceutical Supplies:

The term Privatization has generally been defined as any process that aims to shift functions and responsibilities (totally or partially) from the government to the private. More broadly meaning, it refers to the restriction of government’s role and putting forward some methods or policies in order to strengthen the free market economy [20]. Privatization can be an ideology (for those who oppose government and seek to reduce its size, role, and costs, or for those who wish to encourage diversity, decentralisation, and choice) or a tool of government (for those who see the private sector as more efficient, flexible, and innovative than the public sector) [20]. In [20]contends that “the invisible hand of the market is more efficient and responsive to the consumer needs and the public administrative budgets consume large portion of tax monies that could otherwise be used for service delivery”. The emphasis is on improving the efficiency of all public enterprises, whether retained or divested.

Privatization May Take Many Forms Including: Elimination of a public function and its assignment to the private sector for financial support as well as delivery (police, and fire departments, schools, etc.). Opponents characterize this as “loadshedding”.

Deregulation: The elimination of government responsibility for setting standards and rules concerning goods or services.

Assets sales: The selling of a public asset (city buildings, and sports stadiums) to private firms.

Vouchers: Are the government provided or financed cards or slips of paper that permit private individuals to purchase goods or services from a private provider (food stamps) or circumscribed list of providers.

Franchising: The establishment of models by the public sector that is funded by government agencies but implemented by approved private providers.

Contracting: The government financing of services, choice of service provider, and specification of various aspects of the services laid out in contracts with the private-sector Organization that produces or delivers the services.

User fees: Public facilities such as hospitals that maximise their income or finance some goods from private sources, either through drug sales or other services. This kind of Privatization has been applied in Sudan since the early 1990s, as the health financing mechanism (especially for medicines).

In Sudan, the government has decided to distance itself from direct involvement in business, and thus divest most of its interests whether in loss- or profit-making public enterprises. The public reform programme was set firmly in the context of the broader reforms [20], which were introduced in 1992. It had become clear the previous policies had delivered led to poor results. This reform based on the transfer of activities vested with the government institutions to the private sector. It signaled the government intention to reduce its presence in the economy, to reduce the level and scope of public spending and to allow market forces to govern economic activities. Privatization also forms part of the government strategy of strengthening the role of the private in the development to achieve the vision of the 25 years strategy in which the private sector will be the engine for economic growth. The privatization started in 1992 by liberalization of local currency, foreign exchange transactions, internal and external trade, prices and health services (e.g., user fee as a mechanism of drug financing and other services). This reform had led to greater reliance on individual initiative and corporate accountability rather than on government as a decision-maker in business matters. The Privatization policy goal is to improve the performance of the public sector companies, so that they can contribute to the growth and the development of the economy by broadening ownership, participation in management, and stimulating domestic and foreign private investment. The following are the primary objectives, which have been defined in the government’s policy statement on public sector reform [20]:

a. Improve the operational efficiency of enterprises that are currently in the public sector by exposing business and services to the greatest competition for the benefit of the consumer and the national economy.

b. Reduce the burden of public enterprises on the government’s budget by spreading the shares’ ownership as widely as possible among the population.

c. Expand the role of the private sector in the economy (permitting the government to concentrate on the public resources) on its role as provider of basic public services, including health, education, social infrastructure, and to compact the side effects of the Privatization.

d. Encourage wider participation of the people in the ownership and management of business.

In pursuing the primary objectives, the privatization policy aims to transform the performance of most significant enterprises in the public sector and ensure liquidation of all viable and non-viable public enterprises as soon as possible through commercialization, restructuring and divesture. Public sector reform efforts are thus aimed at reducing government dominance and promoting a larger role for the private sector, while improving government’s use of resources. Movement towards those goals in some countries is supported by components of a structural adjustment loan, which helped initiate the programme and establish the legislative and institutional base. Opponents argue that the original objectives of state ownership were to ensure the corporate sector of the economy was in national hands rather than being controlled by either foreign investors or the minorities that enjoyed business dominance upon independence. A further objective was to use investment in state firms to accelerate development in a situation, in which private sector was reluctant to take risks.

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