Unregistered Medicines Research Articles

Managing medicine shortages.

Medicine shortages are increasingly common and disruptive to the optimal delivery of health care. They are caused by a variety of factors, including manufacturing and supply-chain issues, regulatory and trade issues, and fluctuations in demand. Prescribers and pharmacists in Australia can manage a shortage by switching to another brand, strength or dosage form of the same medicine, switching to a different registered medicine, or accessing an unregistered medicine that has been made available via section 19A of the Therapeutic Goods Act 1989 or through the Special Access Scheme. There are a range of resources and tools that can assist clinicians with identifying and managing medicine shortages in Australia. Shortages are managed most effectively when prescribers, pharmacists and nurses work together, in collaboration with patients, to develop, implement and monitor strategies to manage the shortage.

Stakeholder perceptions of issues and possible solutions to access to oncology medicines: a case study of multi-stakeholder engagement

Aim This case study reports on a series of multi-stakeholder dialogues on challenges to access to oncology medicines in both the public and private sectors. Methods Key stakeholders, identified from various points in the pharmaceutical supply chain, were invited to attend a series of virtual discussion sessions to address specific medicines access challenges to the provision of cancer care in South Africa. For each session, a case scenario, based on a real world situation/event was presented for discussion, and viable solutions and areas requiring further research or legislative changes were identified. Topics covered in these discussions included registration pathways and obstacles; limitations of current medicine pricing policies; alternate reimbursement models; funders’ initiatives to ensure access to oncology medicines; and essential medicine selection and procurement in the public sector. Findings The key issues raised in the discussions included: non-transparency in the approval and pricing of unregistered medicines accessed in terms of section 21 of the Medicines and Related Substances Act of 1965 (as amended); commercial decisions related to the small market for oncology medicines in South Africa; inequities between public and private sector access; alternate forms of price negotiation in the private sector; the restrictions imposed by the single exit price model; and the role of co-payments for those medicines not included as prescribed minimum benefits. Conclusions There is a clear need for a forum where all stakeholders and actors in this field can engage in discussions to find solutions to the oncology medicines access conundrum, including the development of legislative amendments.

Prevalence of substandard, falsified, unlicensed and unregistered medicine and its associated factors in Africa: a systematic review.

Substandard, falsified, unlicensed, and unregistered medicines pose significant risks to public health in developed and developing countries. This systematic review provides an overview of the prevalence of substandard, falsified, unlicensed, and unregistered medicine and its associated factors in Africa. Articles published from April 2014 to March 2024 were searched in Google Scholar, Science Direct, PubMed, MEDLINE, and Embase. The search strategy focused on open-access articles published in peer-reviewed scientific journals and studies exclusively conducted in African countries. The quality of the studies was assessed according to the Medicine Quality Assessment Reporting Guidelines (MEDQUARG). This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). Of the 27 studies, 26 had good methodological quality after a quality assessment. Of the 7508 medicine samples, 1639 failed at least one quality test and were confirmed to be substandard/falsified medicines. The overall estimated prevalence of substandard/falsified medicines in Africa was 22.6% (1718/7592). The average prevalence of unregistered medicines was 34.6% (108/312). Antibiotics, antimalarial, and antihypertensive medicines accounted for 44.6% (712/1596), 15.6% (530/3530), 16.3% (249/1530), and 16.3% (249/1530), respectively. Approximately 60.7% (91/150) were antihelmintic and antiprotozoal medicines. Poor market regulatory permission, Free trade zones, poor registration, high demand, and poor importation standards contribute to the prevalence of these problems. Substandard, falsified, and unregistered medicines are highly prevalent in Africa, and attention has not been paid to the problem. Antibiotics, antimalarial, anthelmintic, and antiprotozoal are the most commonly reported substandard, falsified, and unregistered medicines. A consistent supply of high-quality products, enhancement of registration, market regulatory permission, and importation standards are essential to counter the problems in Africa. Preventing these problems is the primary duty of every responsible nation to save lives.

Health alerts for substandard, falsified, and unregistered medical products at the onset of the COVID-19 pandemic in the AmericasAlertas de saúde para produtos médicos abaixo do padrão, falsificados e não registrados no início da pandemia de COVID-19 nas Américas

Identify and analyze incidents of substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic. Detailed search of the websites of regulatory authorities in the Americas. Identification of incidents of substandard, falsified, unregistered, and stolen medicines and medical devices (including in vitro diagnostics). The types of products were determined, as were the stages in the supply chain where they were detected, and the actions taken by authorities. A total of 1 273 incidents were identified in 15 countries (1 087 substandard, 44 falsified, 123 unregistered, and 19 stolen products). The largest number of incidents involved medical devices, disinfectants, and antiseptics. The most frequently reported point in the supply chain was online purchasing. The principal measures taken by the regulatory authorities were: alerts, prohibition of use, prohibition of advertising and manufacture, recall, and monitoring of adverse events. A substantial number of incidents involving substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic were identified. Shortages of supplies, easing of regulatory requirements, and increased demand are factors that may have led to an increase in the number of incidents. The national regulatory authorities of reference reported more frequent detection of incidents and more frequent application of health measures. A regulatory strategy is needed in order to address online sales and ensure the safe distribution of medical products.

АНАЛИЗ НОРМАТИВНО-ПРАВОВОГО РЕГУЛИРОВАНИЯ ХРАНЕНИЯ НЕЗАРЕГИСТРИРОВАННЫХ ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВ В МЕДИЦИНСКИХ И ФАРМАЦЕВТИЧЕСКИХ ОРГАНИЗАЦИЯХ В РОССИЙСКОЙ ФЕДЕРАЦИИ

Compliance with the necessary storage conditions for unregistered medicines by health facilities and pharmacies is one of the most important aspects of medicine provision of patients. Currently, some aspects related to ensuring the storage conditions for unregistered medicines remain insufficiently regulated by the current legislation. The aim of the study is to analyze the legal regulation of the storage in health facilities and pharmacies of unregistered medicines in the Russian Federation which are imported for the purpose of providing medical care to specific patients. The texts of regulatory legal acts of the Russian Federation have been used in this study as well as grammatical and logical methods of their interpretation. It has been shown that at present unregistered medicines can be imported into the Russian Federation to provide medical care to patients for health reasons, including containing narcotic and psychotropic substances. It has been analyzed that this import into the country is provided by a legal entity entitled to it, after which at the regional level such medicines are transferred for storage either to an intermediary pharmaceutical organization or directly to a health facility in which the medicine will be administered to the patient or dispensed for use at home. It has been established that the current legislation of the Russian Federation does not regulate in detail the organization of storage of unregistered medicines. The necessity of developing legal norms regulating the storage of unregistered medicines in health facilities and pharmacies has been presented. The expediency of providing separate storage of unregistered medicines in in health facilities and pharmacies has been substantiated, which, depending on the available space and equipment, can be organized on four levels, which will reduce the likelihood of errors at this stage of their circulation.

АНАЛИЗ НОРМАТИВНО-ПРАВОВОГО РЕГУЛИРОВАНИЯ РЕГЛАМЕНТИРОВАНИЯ УСЛОВИЙ ОТПУСКА НЕЗАРЕГИСТРИРОВАННЫХ ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВ В РОССИЙСКОЙ ФЕДЕРАЦИИ

Currently, some aspects related to the determination of specific dispensing conditions of unregistered medicines remain insufficiently detailed by the current legislation. The aim of the study is to analyze the legal regulation of the determination of the dispensing conditions of unregistered medicines in the Russian Federation which are imported for the purpose of providing medical care to specific patients. The texts of regulatory legal acts of the Russian Federation, information from the instructions for the medical use of medicines in accordance with the online version of the state register of medicines have been used in this study. It has been analyzed that the specific dispensing conditions of medicines are determined by the Ministry of Health of the Russian Federation during their state registration, and subsequently, if appropriate reasons arise, they can be changed. It has been shown that at present, for medicines registered in the Russian Federation, there are the following main dispensing conditions, which can be arranged in the order of their tightening: over-the-counter, by prescription, only in hospitals, for special purposes. It has been established that the current legislation of the Russian Federation does not regulate in detail the dispensing conditions of unregistered medicines imported into the Russian Federation to provide medical care to specific patients for health reasons. It has been proven that, in accordance with the criteria for classifying medicines as specific dispensing conditions, these medicines cannot be over-the-counter medicines, because in any case, they require control over their use by medical professionals. The main difficulty lies in directly determining whether a particular unregistered medicine can be dispensed to a patient or his legal representatives for treatment at home, or whether it should be used exclusively in a hospital has been presented. The necessity of developing a set of organizational and legal measures that ensure the legality, safety and effectiveness of therapy with the use of unregistered medicines, both at home and in hospitals, have been substantiated, which will minimize errors in such pharmacotherapy.

“Enxugando Gelo?”: o trabalho dos profissionais na fiscalização sanitária de medicamentos na internet

Abstract Contemporary society is plagued with uncertainties and vulnerabilities, demanding from regulatory systems the surveillance of unregistered and/or falsified medicines sold online. This study investigates the work of federal health surveillance professionals in the inspection of medicines sold online and the elements that guide their technical decision. A qualitative, single case study based on the ergological approach was conducted between December 2020 and September 2021, with data collected by interviews and participant observation. Ergodialogical maps, developed using Atlas.ti, underlined the analysis of discursive practices classified according to the tri-polar knowledge-action-value schema, resulting in three categories. Professionals are always called upon to decide on and manage unpredictable situations, questioning the institutional capacity to understand and act on the problem. The work thus takes on the sense of “rolling a stone uphill” due to the volume of demands and the limited effects of surveillance on the e-commerce of medicines. Norms, technical knowledge, experience, and social responsibility, among other elements, inform the decision-making process of professionals, who are aware that, by acting, they protect public health. Different forms of knowledge, scientific or experiential, can better qualify decision-making in surveillance, making it more effective, assertive, and transparent.

The use of special approval medicines among pediatric patients in a tertiary care hospital: A reality check

BackgroundSpecial approval medicines (SAMs) are medicines used with approval from the Director General of Health Malaysia when the therapeutic options within regulatory and formulary boundaries appear unsuitable or ineffective to treat the patients. ObjectivesTo examine and characterize the use of SAMs among children in a Malaysian tertiary care hospital. MethodsThe named-patient basis SAM application forms, cover letter, pharmacist review summary and patient monitoring forms available at the Pharmacy Department between 1st January 2019 and 31st December 2020 were reviewed. Unprocessed, unapproved and stock-basis applications were excluded. The outcome measures were categories, scope, off-label use and cost of SAM. Per-patient data were analyzed descriptively. ResultsOverall, 1010 patients (mean age of 8.7 ± 5.6 years) were involved in 328 SAMs applications. The most common SAMs pharmacological groups were nervous system (n = 371, 36.7%) and antineoplastic and immunomodulating agents (n = 332, 32.9%). Top three SAMs were melatonin (11.5%), scopolamine (7.6%) and cholecalciferol (7.1%). A total of 837 (82.9%) and 513 (50.8%) patients were involved in the SAMs applications for non-formulary and unregistered medicines, respectively. Unregistered, non-formulary medicines were applied for 47.3% (n = 478) of the patients. The majority of the scope for SAMs (64.7%) were to substitute the available alternatives in the national formulary which were ineffective or sub-optimal for the patients. Among the 262 patients with repeat applications, 93.8% reported disease or symptom improvement while 1.9% experienced side effects. Up to 17% of SAMs analyzed in this study were used for off-label indications. The total cost of the SAMs was RM8,748,358.38 (USD 2,090,418.86). ConclusionThe use of SAMs among children in this hospital involved unregistered, non-formulary medicines used to substitute the available alternatives in the formulary. A concerted effort is warranted in exploring supplementary mechanisms to enhance the medicine registration process and formulary system towards facilitating enhanced provision of treatment for children.

Technical-legal aspects of the normative consolidation of the signs of the objective side of the crime provided for in Article 238.1 of the Criminal Code of the Russian Federation

The article analyzes the peculiarities of the regulation of criminal liability for the circulation of falsified, substandard and unregistered medicines, medical devices and the turnover of falsified biologically active additives (Article 238.1 of the Criminal Code of the Russian Federation). First of all, the author highlights violations of the general rules of legislative technique, which provide for compliance with the requirements of saving regulatory material, the use of similar terms in the construction of homogeneous compositions of crimes, etc. The author notes that it is necessary to normalize the level of punishability of single-order elements of crimes enshrined in Articles 235.1 and 238.1 of the Criminal Code of the Russian Federation by simultaneously indicating the large size of the acts committed in these criminal law prohibitions. The article notes the need for additional criminological analysis of other possible illegal actions with falsified, substandard or unregistered medicines, medical products and biologically active additives, such as - purchase, storage, transportation. The author also offers various options for interpreting the signs of the objective side, such as production and marketing, examines the features and controversial aspects of the qualification of an unfinished crime, explores the issues of excluding criminal liability in the manufacture of medicines and medical devices in the process of conducting clinical trials and research, and carrying out export operations.

Availability of essential medicines for children with cancer in Sri Lanka: a prospective cohort study

The WHO Model List of Essential Medicines for children (2019 version) contains 39 antineoplastic and supportive medicines deemed essential for the successful treatment of children with cancer. The availability of these medicines varies across countries, but most reports are retrospective or short term. This study tracked the availability of these medicines in Sri Lanka's only treatment centre for childhood cancer, the National Cancer Institute of Sri Lanka, over 1 year, and examined initial mitigation strategies and implications. We prospectively tracked the availability of essential medicines at the National Cancer Institute of Sri Lanka in a customised database from April 1, 2019, to March 31, 2020. Consumption volumes and unit prices were extracted from the Sri Lankan Ministry of Health's Medical Supplies Management Information System. Availability was mapped against regimens used to treat childhood cancers, including WHO Global Initiative for Childhood Cancer index cancers, in Sri Lanka and by the International Society of Paediatric Oncology. Descriptive analyses and linear regression were used to assess factors associated with the unavailability of medicines. 31 (79%) of 39 medicines listed in the WHO Model List of Essential Medicines for children are in the Sri Lankan Essential Medicine List and 36 (92%) of 39 (48 formulations) are registered for use. Thioguanine, arsenic, and realgar-Indigo naturalis were the unregistered medicines. Over the study period, less than half (17 [44%]) of medicines were consistently available for 100% of the study period, 14 (36%) were available 75-100% of the study period, three (8%) between 50-75% of the study period, and two (5%) for less than 50% of the duration of the study period. The least available drug was procarbazine (available only on 212 [58%] of 366 days in the total study period). The availability of medicines did not reach 100% on any day in the study period. No substantial monthly variability was noted, but the best availability was in August, 2019, and the worst in January, 2020. Applying regimen-based analyses for acute lymphoblastic leukaemia, 12 stockout episodes affected seven (18%) medicines (median 37·5 consecutive days, IQR 12·0-62·0), whereas stockout mitigation strategies (low stock periods not resulting in stockout) were effective in 11 instances; only three (8%) medicines did not have alternate formulations or substitutions during stockouts (vincristine, cytarabine, and mercaptopurine). Of the WHO Global Initiative for Childhood Cancer index cancers, Hodgkin lymphoma was the most affected by stockouts, and retinoblastoma was the least affected. Annual consumption volumes (p=0·13), unit cost (p=0·5), and annual costs per medicine (p=0·091) were not significantly associated with medicine unavailability. Non-availability of essential medicines is an important problem to be addressed for children with cancer in Sri Lanka. This study showed the feasibility of prospective essential medicines tracking at the point-of-care, and how data visibility can inform stock and inventory management and help to identify mitigation strategies for stockouts. None.

Importation and distribution of unregistered medicines in the public sector: similarities, differences, and shared challenges among Southern African Development Community (SADC) countries

BackgroundThe purpose of the study was to assess the requirements for approval of the importation of unregistered medicines for use in the public sector in the Southern African Development Community (SADC) countries.MethodsThe study reviewed the legal provisions and requirements to be fulfilled when importing unregistered medicines for the public sector in SADC countries relative to two comparators drawn from countries with stringent regulatory systems through extant document analysis. The relative implementation index score was calculated and used to measure the level of implementing legal provisions and requirements to be fulfilled. Analysis was performed using the STATA software package.ResultsApproximately 13 out of 16 SADC countries had a relative implementation index below 50%. The aggregated implementation index across all SADC countries was 44%, ranging from 4 to 54%, while the two comparators had a relative implementation index of 81% and 85%, respectively.ConclusionImplementing the minimum requirements for importing unregistered medicines for the public sector was deficient compared to the jurisdictions with stringent regulatory systems, and wide implementation gaps also existed within the SADC region.

Patterns-of-prescription-medicines-sale-through-e-marketplace-in-malaysia-and-associating-factors

Introduction: Self-diagnose and obtaining various health products via the Internet were extremely risky practices as it may increase the risks of patient injury or even death. Objective: This study aims to explore the patterns of prescription medicines sale through e-marketplace (specifically: Shopee) in Malaysia as well as the associated factors. Method: Cross-sectional study secondary data of 983 Advertisement Screening Reports (reported from 1st January 2020 - 30th June 2020) in Johor State were collected. Descriptive statistics using frequency, percentages and/ bar charts using Microsoft Excel 2013 were used to report on the patterns of prescription medicines sale through e-marketplace (specifically: Shopee) in Malaysia based on types of prescription medicines that are being advertised, registration status of prescription medicine that are being advertised as well as frequently violated Malaysia’s law related to prescription medicine by sellers on Shopee. Factors associated were explored by Simple and Multiple Logistic Regressions using IBM SPSS Version 22. Results and Discussion: 796 out of 852 (93.4%) prescription medicines samples were not registered with the Drug Control Authority, Malaysia’s Health Ministry. Hormones (62.6%, while sex hormones which were anabolic steroids showed the highest frequency; 58.3%) were the highest prescription medicines sold through the e-marketplace in Malaysia, followed by antibiotics, clomiphene (fertility drug), sibutramine (slimming pill) and prostaglandin and its synthetic derivatives (abortion pill) denote 4.8%, 2.2%, 1.8%, 0.4% respectively. The unregistered prescription medicines were found to be the highest to violate Section 13(a) of Poison Act 1952 which include 766 samples. Multiple logistic regression tests indicate that sellers who violated Regulation 7(1)(a) of Control of Drug and Cosmetic Regulations 1984 (Adjusted OR: 728.63; 95%CI; 194.69, 2726.96%; p = 0.000) have higher chance to sell unregistered medicines through e-marketplace compared to those who violated Section 13 (a) of Poison Act 1952 (Adjusted OR: 0.012; 95%CI; 0.002, 0.058%; p = 0.000), and Section 4B of Malaysia Advertisement and Sale Act 1956 (Adjusted OR: 0.060; 95%CI; 0.014, 0.260%; p = 0.000). Conclusion: The findings in this study may give a brief idea for improving the current practice in order to curb the freely illegal prescription medicines sale through e-marketplace (specifically: Shopee) without the supervision of professionals.

Implementation of medicinal cannabis in Australia: innovation or upheaval? Perspectives from physicians as key informants, a qualitative analysis

ObjectiveWe sought to explore physician perspectives on the prescribing of cannabinoids to patients to gain a deeper understanding of the issues faced by prescriber and public health advisors in the...

Некоторые вопросы конструирования состава преступления, предусмотренного ст. 238.1 УК РФ

Negative trends in the consumer sphere affected the pharmaceutical industry, which was flooded with medicines, medical products, food additives of dubious origin and quality. Fake and expired medical products pose both a direct and indirect threat to human health (and, taking into account the scale and distribution – to the health of the population), since they do not have a proper therapeutic effect. The article deals with the issues of criminal law response to the circulation of falsified, substandard and unregistered medicines, medical devices and the turnover of falsified dietary supplements.

Availability of essential medicines in Pakistan-A comprehensive document analysis.

IntroductionAccess to essential medicines (EMs) is a basic human right. Non-availability and shortages of EMs are reported for Pakistan but there is insufficient data to define the nature and magnitude of this problem. The current study is designed to systematically analyze the medicines included in the National Essential Medicines List (NEML) for their availability through comprehensive document analysis.MethodsAn expanded list of medicinal items was developed using the NEML of Pakistan (2018) to enlist individual medicines with their specifications. Registration status of the medicines was searched using three publicly accessible information sources; Pharmaguide 25th Edition, 2018–19, the on-line Drug Information System, and the Mobile Application Pharmapedia followed by a later 3-step validation of the data. The unregistered EMs were then further categorized into three subgroups in accordance with their possible remedial strategies.FindingsThe 19 studied categories comprised 690 EMs and it was found that 179 (26%) of these EMs don not have a registration status. However, it was also identified that the availability of 47 (26.2%) out of 179 unregistered EMs can be enssured by strengthening compounding services, and prioritizing registration of age-appropriate formulations. Availability of another 39 (21.7%) such medicines can be ensured by revising the NEML or the product registrations for the slight differences in their different specifications. The categories showing high proportion of unregistered medicines included anti-Parkinson’s medicines (100%), antidotes and other substances used in poisoning (60%), diuretics (47%), anticonvulsants/antiepileptics (42%), hormones and other endocrine medicines and contraceptives (38%), medicines for mental and behavioral disorders (30%), anti-infectives (27%), medicines for pain and palliative care (26%), medicines for neonatal care (25%), medicines for diseases of joint (25%), gastrointestinal medicines (24%) and cardiovascular medicines (15%).ConclusionThe study shows the absence of registration status of a significant number of EMs in Pakistan. This could be major barrier in their access. Strategies are needed to strengthen the processes of their registration on priority basis.

Understanding forgotten exposures towards achieving Sustainable Development Goal 3: a cross\u2010sectional study on herbal medicine use during pregnancy or delivery in Tanzania

BackgroundIn most of the sub-Sahara African countries, use of herbal medications is widely practiced during pregnancy or delivery for various reasons despite uncertainties on their pharmacological profiles. Use of unregistered herbal medicines has the potential of causing adverse health effects to the mother and the newborn, thus deterring achievement of Sustainable Development Goal 3, which aims to “ensure healthy lives and promote well-being for all at all ages”. One of the targets is on reduction of morbidity and mortality among mothers and newborns. This study investigated use of herbal medicines and predictors of usage during pregnancy or delivery as a forgotten exposure towards understanding some of the challenges in achieving Sustainable Development Goal 3.MethodsThis cross-sectional quantitative study gathered information from women who delivered a live-born baby in the preceding two years. Using a two-stage-sampling technique, women attending reproductive, maternal and child health clinics in Tabora were selected and interviewed. Proportions were compared using chi-square test and Poisson regression analysis was performed to determine independent correlates of herbal medicine use.ResultsOf 340 recruited women, 208 [61.2 %; 95 % confidence interval: 55.4, 66.3 %] used herbal medicines during pregnancy or delivery. Major reasons for use included accelerating labour, 81 (38.9 %) and reducing labour pains, 58 (27.9 %). Women who made less than four antenatal visits had a 24 % higher adjusted prevalence ratio of using herbal medicines as compared to those who had at least four visits [adjusted prevalence ratio:1.24; 95 % confidence interval: 1.02, 1.50, p = 0.03]. Furthermore, the adjusted prevalence ratio of using herbal medicines was 35 % higher among women who were not discouraged by health care providers against their use as compared to those who were discouraged (adjusted prevalence ratio: 1.35; 95 % confidence interval: 1.13, 1.60, p = 0.01).ConclusionsUse of herbal medicines during pregnancy or delivery among women in Tanzania is common. Independent predictors of herbal medicine use were number of antenatal visits and stance of maternity health care providers on their use. Comprehensive investigations on the magnitude, patterns and predictors of use of herbal medicines during pregnancy or delivery are warranted.

Ivermectin in the treatment of COVID-19- friend or foe?

The global number of deaths due to COVID-19 is almost at the two million mark, with over 35 000 deaths in South Africa. Although there are hopes of a safe and effective vaccination programme, the increasing number of COVID-19 cases in the country is putting a significant strain on the healthcare system. Ivermectin, an antiparasitic drug, has been widely published on social media platforms and news outlets as a so-called miracle drug for the treatment of COVID-19. Ivermectin is not registered in SA as a drug for human use, but rather as a veterinary and agricultural product. Currently, from a small number of randomised controlled trials (RCTs), there does seem to be a signal of evidence for the use of ivermectin in the management of COVID-19. Pharmacists must, however, remain cognisant of their ethical responsibilities as well as the applicable regulations that prohibit the procurement and dispensing of any unregistered medicine.

A survey of the usage and storage practices of veterinary medicines among communal cattle farmers in the Kabbe South Constituency, Zambezi region.

Veterinary medicines are an indispensable tool for animal disease control and prevention. Misuse, improper handling and storage can render veterinary medicines less effective. A cross-sectional study was carried out on 60 cattle farmers in the Kabbe South Constituency of the Zambezi region in Namibia. The objective of the study was to find out the usage and storage practices of veterinary medicines. Selected farmers were interviewed using semi-structured questionnaires. Results of the study showed that the majority of respondents were males (78.3%, n=47) with at least primary school level education. Overall, farmers acquired and used 13 different types of veterinary medicines from licensed shops and pharmacies (73.4%, n=44), the state veterinary office (23.3%, n=14) and from unregistered veterinary medicine agents (3.3%, n=2). The medicines comprised of antibiotics (n=4); vaccines (n=3); combination of ectoparasiticide and anthelmintic (n=2), ectoparasiticide (n=1), anthelmintic (n=1) and vitamins (n=2). Although 36.7% (n=22) of the farmers owned or had access to a refrigerator, the majority (86.7%, n=52) did not maintain the cold chain. Most of the respondents (93.3%, n=56) self-diagnosed animal diseases and decided on the treatment without consulting a veterinarian. Oxytetracycline was the most commonly used veterinary medicine and was used at less than the recommended dose of 1ml/10kg by most respondents (83.3%, n=50). Although farmers sourced veterinary medicines from licensed retailers, the break in the cold chain and the under dosing of medicines may impair effectiveness. Self-diagnosis and treatment of animal diseases promotes misuse and the development of antibiotic resistant bacteria in cattle which may render antibiotics on the market less effective. The training of all stakeholders along the veterinary medicine value chain in the region is recommended.

Substandard, falsified and unregistered medicines in Latin America, 2017-2018.

ABSTRACTObjective.To assess all the incidents of substandard, falsified and unregistered medicines in 2017 and 2018 in Latin America, determining the types of products affected, stages of the supply chain in which incidents were detected, quality deviations identified in tested samples, and regulatory measures taken by authorities.Methods.A comprehensive search of the websites of the Latin American national regulatory authorities was conducted, identifying all eligible incidents during 2017-2018. Standardized values were collected from each incident for pre-determined variables: country, year, type of incident, therapeutic group, supply chain, regulatory measures and laboratory data.Results.A total of 596 incidents in 13 countries were included (236 substandard, 239 falsified, 116 unregistered and 5 stolen). The therapeutic categories with the highest incidents were: anti-infectives, medicines for pain/palliative care, hormones/contraceptives, medicines for the respiratory tract, and medicines for mental/behavioural disorders. The most common places where incidents were detected were commercial establishments, pharmacies, health services and manufacturers. The most recurrent quality deviations were failure in parameters (appearance or physicochemical), incorrect labelling, different quantity of active pharmaceutical ingredient, presence of unknown particles, and microbiological contamination. The most frequent regulatory measures identified were alerts, withdrawals, seizures, and prohibition of marketing/distribution/use.Conclusions.In Latin America, substandard, falsified and unregistered medicines persist as a highly prevalent problem. An advanced degree of regulatory development in countries is associated with higher incident detection/reporting rates and a more comprehensive set of measures. The pharmaceutical supply chain is more vulnerable in its final node. Quality deviations identified in tested samples pose serious risks to public health.

KNOWLEDGE, ATTITUDE AND PRACTICE OF UNREGISTERED MEDICINES AMONG PATIENTS WITH CHRONIC DISEASE AT URBAN HEALTH CLINIC, KELANTAN, MALAYSIA

Introduction: Products registered with the National Pharmaceutical Regulatory Agency (NPRA) have two main features: MAL Registration Number and Meditag™ Hologram sticker. Both of these features need to be displayed on each pack of drug sales. Missing either one or both above features consider as unregistered medicines. This study aims to determine the prevalence and factors associated with knowledge, attitude and practice of unregistered medicines usage among patients with chronic disease attending Klinik Kesihatan Bandar Kota Bharu, Kelantan. Methods: A cross-sectional study involving 108 respondents using convenient sampling was conducted at the outpatient unit of Klinik Kesihatan Bandar Kota Bharu, Kelantan, Malaysia, from June 2019 to July 2019. Results: The prevalence of unregistered medicines usage was 15.7%. Although the respondents had good knowledge about unregistered medicines. More than half (64.8%) of respondents have good knowledge of unregistered knowledge and 91.7% of respondents have negative attitude towards unregistered medicines. Factors associated with practice of unregistered medicines use is found to be level of education and perceived of health believe. Lower education and perceived benefit of unregistered medicines 4 times and 12 times more likely to take unregistered medicines respectively compare to higher education level and perceived no health benefit. Conclusion: In conclusion, prevalence of unregistered medicines usage was 15.7%. More than half (64.8%) of the respondents were categorized as having good knowledge. We need to strengthen our education program to modify patient's belief on the non-benefit using unregistered medicines.