Biopharmaceutical optimization in neglected diseases for paediatric patients by applying the provisional paediatric biopharmaceutical classification system.

AIMS: Unavailability and lack of appropriate, effective and safe formulations are common problems in paediatric therapeutics. Key factors such as swallowing abilities, organoleptic preferences and dosage requirements determine the need for optimization of formulations. The provisional Biopharmaceutics Classification System (BCS) can be used in paediatric formulation design as a risk analysis and optimization tool. The objective of this study was to classify six neglected tropical disease drugs following a provisional paediatric BCS (pBCS) classification adapted to three paediatric subpopulations (neonates, infants and children). METHODS: Albendazole, benznidazole, ivermectin, nifurtimox, praziquantel and proguanil were selected from the 5th edition of the Model List of Essential Medicines for Children from the World Health Organization. Paediatric drug solubility classification was based on dose number calculation. Provisional permeability classification was based on log P comparison versus metoprolol log P value, assuming passive diffusion absorption mechanisms and no changes in passive membrane permeability between paediatric patients and adults. pBCS classes were estimated for each drug, according to different doses and volumes adapted for each age stage and were compared to the adult classification. RESULTS: All six drugs were classified into provisional pBCS in the three paediatric subpopulations. Three drugs maintained the same classification as for adults, ivermectin and benznidazole changed solubility class from low to high in neonates and proguanil changed from low to high solubility in all age stages. CONCLUSION: Provisional pBCS classification of these six drugs shows potential changes in the limiting factors in oral absorption in paediatrics, depending on age stage, compared to the adult population. This valuable information will aid the optimization of paediatric dosing and formulations and can identify bioinequivalence risks when comparing different formulations and paediatric populations.

Integrating theoretical and experimental permeability estimations for provisional biopharmaceutical classification: Application to the WHO essential medicines.

The accuracy of the provisional estimation of the Biopharmaceutics Classification System (BCS) is heavily influenced by the permeability measurement. In this study, several theoretical and experimental models currently employed for BCS permeability classification have been analysed. The experimental models included the in situ rat intestinal perfusion, the ex vivo rat intestinal tissue in an Ussing chamber, the MDCK and Caco-2 cell monolayers, and the parallel artificial membrane (PAMPA). The theoretical models included the octanol-water partition coefficient and the QSPeR (Quantitative Structure-Permeability Relationship) model recently developed. For model validation, a dataset of 43 compounds has been recompiled and analysed for the suitability for BCS permeability classification in comparison with the use of human intestinal absorption and oral bioavailability values. The application of the final model, based on a majority voting system showed a 95.3% accuracy for predicting human permeability. Finally, the present approach was applied to the 186 orally administered drugs in immediate-release dosage forms of the WHO Model List of Essential Medicines. The percentages of the drugs that were provisionally classified as BCS Class I and Class III was 62.4%, suggesting that in vivo bioequivalence (BE) may potentially be assured with a less expensive and more easily implemented in vitro dissolution test, ensuring the efficiency and quality of pharmaceutical products. The results of the current study improve the accuracy of provisional BCS classification by combining different permeability models.

Essential medicines for emergency care in Africa.

OBJECTIVES: Essential medicines lists (EMLs) are efficient means to ensure access to safe and effective medications. The WHO has led this initiative, generating a biannual EML since 1977. Nearly all countries have implemented national EMLs based on the WHO EML. Although EMLs have given careful consideration to many public health priorities, they have yet to comprehensively address the importance of medicines for treating acute illness and injury. METHODS: We undertook a multistep consensus process to establish an EML for emergency care in Africa. After a review of existing literature and international EMLs, we generated a candidate list for emergency care. This list was reviewed by expert clinicians who ranked the medicines for overall inclusion and strength of recommendation. These medications and recommendations were then evaluated by an expert group. Medications that reached consensus in both the online survey and expert review were included in a draft emergency care EML, which underwent a final inperson consensus process. RESULTS: The final emergency care EML included 213 medicines, 25 of which are not in the 2017 WHO EML, but were deemed essential for clinical practice by regional emergency providers. The final EML has associated recommendations of desirable or essential and is subdivided by facility level. Thirty-nine medicines were recommended for basic facilities, an additional 96 for intermediate facilities (eg, district hospitals) and an additional 78 for advanced facilities (eg, tertiary centres). CONCLUSION: The 25 novel medications not currently on the WHO EML should be considered by planners when making rational formularies for developing emergency care systems. It is our hope that these resource-stratified lists will allow for easier implementation and will be a useful tool for practical expansion of emergency care delivery in Africa.

The evolution of Reference Drug Lists and Clinical Practice Guidelines in the public health system of a middle-income country.

AIMS: The aims were to analyze the dynamics of the medicines formulary in a middle-income country and to analyze the concordance of the included medicines with the national Clinical Practices Guidelines (CPG). METHODS: Medicines and their indications of use included in the Mexican Reference Drug List (Mex-RDL) from 1996 to 2013 were analyzed. The top 10 indications with the highest number of medicines in 2013 were analyzed retrospectively until 1996 in order to identify the increase in the number of medicines to treat each one, as well as the progressive specificity of the indication according to the International statistical Classification of Diseases (ICD-10). The concordance between the CPG and medicines approved for the top 10 indications was studied. RESULTS: The number of medicines included in the Mex-RDL kept constantly growing from 454 drugs in 1996 to 811 in 2013. Up to 26.3% of these medicines were approved to treat only 10 indications (1.5% of all possible indications of use). Many of these new medicines had been approved for more and more specific indications, while the oldest ones had been approved for general indications. Up to 27.6% of the medicines approved for these top 10 indications do not appear in the updated recommendations of the specific CPG for those indications. CONCLUSIONS: During the last 18 years, the new medicines and indications included in the Mex-RDL were redundant and concentrated into few similar clinical conditions. This is a factor that promotes an irrational use of these medicines and, thus, unnecessarily raises the price of health care, undermines the quality of the health system and probably increases the uncertainty of treatments.

The fuzzy line between needs, coverage, and excess in the Mexican Formulary List: an example of qualitative market width analysis.

PURPOSE: To assess the rationality of the Mexican Formulary List (MEX-LIST). METHODS: MEX-LIST was compared with the World Health Organization Essential Medicines List (WHO-LIST) to identify drugs classified as unmet needs. For the MEX-LIST rationality evaluation, the assessment of a non-sponsored, systematic and unbiased source (Prescrire Journal) was used for medicines not listed in WHO-LIST. The rating scale of Prescrire classifies medicines as Bravo, Real Advance, Offers an Advance, Possibly Helpful, Nothing New (NN), Judgment Reserved (JR), or Not Acceptable (NA) depending on their comparative therapeutic value. The NN, JR, and NA categories of medicines are further classified as non-added value. RESULTS: The MEX-LIST contains 771 medicines, which is 2.4-fold more than the WHO-LIST (n = 321). Up to 236 medicines in the MEX-LIST perfectly match the WHO-LIST medicines, 40 could be considered as reasonable substitutes, but 45 (14.0 %) present in the WHO-LIST are not present in the MEX-LIST, including an oversupply of 495 medicines. Rationality level could be analyzed for 353 of these: 43.1 % (n = 152) were classified as NN, 12.2 % (n = 43) as NA, and 6.2 % (n = 22) as JR due to limited available information. In summary, 61.5 % of the evaluated medicines present in the MEX-LIST but not included in the WHO-LIST (n = 217) can be considered drugs that do not add substantial therapeutic benefits, this accounts for 28.1 % of the medicines in the MEX-LIST. CONCLUSIONS: MEX-LIST is characterized by a twofold irrationality in that essential medicines to treat prevalent diseases are missing and medicines without any rational added value are in oversupply. This type of study can be easily applied to other countries with the aim of providing a forum for further discussion and improvement of the medicines offered by their national formularies.

Where are we now: assessing the price, availability and affordability of essential medicines in Delhi as India plans free medicine for all.

BACKGROUND: Inequitable access to medicines is a major weakness in the Indian health care system. Baseline data needed to develop effective public health policy and provide equitable access to essential medicines. The present survey was conducted to investigate the price, availability, and affordability of fifty essential medicines in the public and private sector in Delhi, India using standardized WHO/HAI methodology. METHODS: Data on procurement price and availability was collected (July-October 2011) from three public healthcare providers: the federal (central) government, state government and Municipal Corporation of Delhi (MCD). Data on price and availability of medicines was collected from private retail and chain pharmacies of a leading corporate house. Prices were compared to an international reference price (expressed as median price ratio-MPR). RESULTS: The procurement price of surveyed medicines was 0.53-0.82 times the international reference price-IRP. However, the overall mean availability of surveyed medicines in facilities under state government and MCD was 41.3% and 23.2%, respectively. The overall mean availability of medicines in three tertiary care facilities operated by the federal government was 49.3%. Availability of generic medicines was much higher in the private sector. Off-patented medicines, like diazepam, diclofenac, and doxycycline had the highest MPRs. The price ratio between procurement and retail was as high as 28 (range 11-28) for certain medicines. Seven-day treatment with a popular brand of amoxicillin+clavulanic acid or one inhaler each of budesonide and salbutamol cost 2.3 and 1.4 days' wages for the lowest paid government worker. A majority of India's population cannot afford these prices. CONCLUSIONS: This study revealed that procurement prices of surveyed medicines were reasonable in comparison to IRP. However, variation in procurement prices of certain medicines by different public procurement agencies was noted. Availability of medicines was very poor in public sector facilities, which are the primary source of free medicines for a majority of India's low-income population. Availability of medicines is better in private retail pharmacies but affordability remains a big challenge for a majority of the population. These data have significant policy implications that could help in amending policies to increase the access to essential medicines for India's population.

Comparison of antibiotics included in national essential medicines lists of 138 countries using the WHO Access, Watch, Reserve (AWaRe) classification: a cross-sectional study.

BACKGROUND: The WHO Model List of Essential Medicines classified antibiotics into Access, Watch, and Reserve (AWaRe) categories for the treatment of 31 priority bacterial infections as a tool to facilitate antibiotic stewardship and optimal use. We compared the listing of antibiotics on national essential medicines lists (NEMLs) to those in the 2019 WHO Model List and the AWaRe classification database to determine the degree to which NEMLs are in alignment with the AWaRe classification framework recommended by WHO. METHODS: In this cross-sectional study, we obtained up-to-date (data after 2017) NEMLs from our Global Essential Medicines (GEM) database, WHO online resources, and individual countries' websites. From the 2019 WHO Model List we extracted, as a reference standard, a list of 37 antibiotics (44 unique antibiotics after accounting for combination drugs or therapeutically equivalent drugs as specified by WHO) that were considered essential in treating 31 of the most common and severe clinical infectious syndromes (priority infections). From the WHO AWaRe Classification Database, which contains commonly used antibiotics globally, we extracted a list of 122 AWaRe antibiotics listed by at least one country in the GEM database. We then assessed individual countries' NEMLs for listing of the 44 essential and 122 commonly used antibiotics, overall and according to AWaRe classification group. We also evaluated and summarised the listing of both first-choice and second-choice treatments for the 31 priority infections. A total coverage score was calculated for each country by assigning a treatment score of 0-3 for each priority infection on the basis of whether first-choice and second-choice treatments, according to the 2019 WHO Model List, were included in the country's NEML. Coverage scores were then compared against the score of the 2019 WHO Model List and across World Bank income groups and WHO regions. FINDINGS: As of July 7, 2020, we had up-to-date NEMLs for 138 countries. Of the 44 unique essential antibiotics, 24 were Access, 15 were Watch, and five were Reserve. The median number of total essential antibiotics listed across the 138 NEMLs was 26 (IQR 21-32). 102 (74%) countries listed at least 22 (50%) of the 44 essential antibiotics. The median number of total AWaRe antibiotics listed by the 138 countries was 35 (IQR 29-46), of Access antibiotics was 18 (16-21), of Watch antibiotics was 16 (11-22), and of Reserve antibiotics was one (0-2). 56 (41%) countries did not list any essential Reserve antibiotics. 131 (95%) countries had coverage scores of at least 60, equivalent to at least 75% of the score of the 2019 WHO Model List, which was 80. Nine (7%) countries listed fewer than 12 of 24 essential Access antibiotics, and seven (5%) did not list sufficient first-choice and second-choice treatments for priority infections (ie, they had coverage scores lower than 60). Of the 31 priority infections, acute neonatal meningitis and high-risk febrile neutropenia did not have enough listed treatments, with 82 (59%) countries listing no treatment for acute neonatal meningitis and 84 (61%) countries listing only a first-choice treatment, only a second-choice treatment, or no treatment for high-risk febrile neutropenia. Coverage scores differed between countries on the basis of World Bank income groups (p=0·025). INTERPRETATION: Our findings highlight potential changes to the antibiotics included in NEMLs that would increase adherence to international guidance aimed at effectively treating infectious diseases while addressing antimicrobial resistance. FUNDING: Canadian Institutes of Health Research and Ontario Strategy for Patient Oriented Research Support Unit.

Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary analysis.

BACKGROUND: WHO and Health Action International (HAI) have developed a standardised method for surveying medicine prices, availability, affordability, and price components in low-income and middle-income countries. Here, we present a secondary analysis of medicine availability in 45 national and subnational surveys done using the WHO/HAI methodology. METHODS: Data from 45 WHO/HAI surveys in 36 countries were adjusted for inflation or deflation and purchasing power parity. International reference prices from open international procurements for generic products were used as comparators. Results are presented for 15 medicines included in at least 80% of surveys and four individual medicines. FINDINGS: Average public sector availability of generic medicines ranged from 29.4% to 54.4% across WHO regions. Median government procurement prices for 15 generic medicines were 1.11 times corresponding international reference prices, although purchasing efficiency ranged from 0.09 to 5.37 times international reference prices. Low procurement prices did not always translate into low patient prices. Private sector patients paid 9-25 times international reference prices for lowest-priced generic products and over 20 times international reference prices for originator products across WHO regions. Treatments for acute and chronic illness were largely unaffordable in many countries. In the private sector, wholesale mark-ups ranged from 2% to 380%, whereas retail mark-ups ranged from 10% to 552%. In countries where value added tax was applied to medicines, the amount charged varied from 4% to 15%. INTERPRETATION: Overall, public and private sector prices for originator and generic medicines were substantially higher than would be expected if purchasing and distribution were efficient and mark-ups were reasonable. Policy options such as promoting generic medicines and alternative financing mechanisms are needed to increase availability, reduce prices, and improve affordability.

Added therapeutic value of new drugs approved in Brazil from 2004 to 2016.

This study aimed to assess the level of therapeutic innovation of new drugs approved in Brazil over 13 years and whether they met public health needs. Comparative descriptive analysis of therapeutic value assessments performed by the Brazilian Chamber of Drug Market Regulation (CMED) and the French drug bulletin Prescrire for new drugs licensed in Brazil, from January 1st 2004 to December 31st 2016. The extent to which new drugs met public health needs was examined by: checking inclusions into government-funded drug lists and/or clinical guidelines; comparing Anatomical Therapeutic Chemical Classification (ATC) codes and drug indications with the list of conditions contributing the most to the national disease burden; and assessing new medicines aimed to treat neglected diseases. 253 new drugs were approved. Antineoplastics, immunossupressants, antidiabetics and antivirals were the most frequent. Thirty-three (14%) out of 236 drugs assessed by the Brazilian chamber and sixteen (8.2%) out of 195 assessed by the French bulletin Prescrire were considered innovative. Thirty-six drugs (14.2%) were selected for coverage by the Brazilian Unified National Health System (SUS), seven of which were therapeutically innovative, and none were aimed to treat neglected disease. About 1/3 of the drugs approved aimed to treat conditions among the top contributors to Brazil's disease burden. Few therapeutically innovative drugs entered the Brazilian market, from which only a small proportion was approved to be covered by the SUS. Our findings suggest a divergence between public health needs, research & development (R&D) and drug licensing procedures.

Insights from the WHO and National Lists of Essential Medicines: Focus on Pediatric Diabetes Care in Africa.

BACKGROUND: Access to essential medicines in pediatric endocrinology and diabetes is limited in resource-limited countries. The World Health Organization (WHO) maintains two non-binding lists of essential medicines (EMLs) which are often used as a template for developing national EMLs. METHODS: We compared a previously published master list of medicines for pediatric endocrinology and diabetes with the WHO EMLs and national EMLs for countries within the WHO African region. To better understand actual access to medicines by patients, we focused on diabetes and surveyed pediatric endocrinologists from 5 countries and assessed availability and true cost for insulin and glucagon. RESULTS: Most medicines that are essential in pediatric endocrinology and diabetes were included in the national EMLs. However, essential medicines, such as fludrocortisone, were present in less than 30% of the national EMLs despite being recommended by the WHO. Pediatric endocrinologists from the 5 focus countries reported significant variation in terms of availability and public access to insulin, as well as differences between urban and rural areas. Except for Botswana, glucagon was rarely available. There was no significant relationship between Gross National Income and the number of medicines included in the national EMLs. CONCLUSIONS: Governments in resource-limited countries could take further steps to improve EMLs and access to medicines such as improved collaboration between health authorities, the pharmaceutical industry, patient groups, health professionals, and capacity-building programs such as Paediatric Endocrinology Training Centres for Africa.

The public production of medicines compared to the National Policy of Medicines and the burden of disease in Brazil.

: The public production of medicines in Brazil by Government Pharmaceutical Laboratories has once again become the object of incentives, and Industrial Development Partnerships are one of the mechanisms adopted for the production of strategic medicines for the Brazilian Unified National Health System (SUS). Considering that burden-of-disease studies have been used as a tool to define priority and essential medicines, the article compares the product portfolios of the country's Official Pharmaceutical Laboratories (OPL) and the list of strategic medicines for the SUS and burden of disease in Brazil in 2008. Of the 205 strategic medicines for the SUS and 111 from the portfolios, 73% and 89%, respectively, are on the National List of Essential Medicines (RENAME 2014). Some strategic medicines for the SUS are already produced by OPL and feature the selection of cancer drugs and biologicals. The current study contributes to the discussion on the public production of medicines in light of the country's current industrial policy and highlights the need to define priority drugs and the role of OPL in guaranteeing access to them.

[The essentiality and rationality of the Brazilian national listing of essential medicines]. / Essencialidade e racionalidade da relação nacional de medicamentos essenciais do Brasil.

One strategy to implement the rational use of medicines is the adoption of an 'essential medicines list'. The objective of this study was to analyze the list of medicines contained in the Brazilian National Relation of Essential Medicines (Rename, 2013) in terms of essentiality and rationality. Essentiality was determined by comparing this list to the 18th Essential Medicines List (EML) published by the World Health Organization (WHO). Drugs which were part of the Brazilian National Relation of Essential Medicines but not included in the EML were assessed using the classification described in La revue Prescrire to detect medications without added therapeutic value. It was discovered that the Brazilian National Relation of Essential Medicines contains 190 medications not included in the EML, of which 63 have no added therapeutic value. In addition, discrepancies were identified between the recommendations of the WHO and the drugs included in the Brazilian National Relation of Essential Medicines. It is concluded that drugs that are non-essential and provide no added therapeutic value should not be included in a list of essential medicines funded by the three Brazilian federal entities.

Free acquisition of psychotropic drugs by the Brazilian adult population and presence on the National List of Essential Medicines

Abstract The aims of the present study were to estimate the free-of-charge acquisition of psychotropic drugs among Brazilian adults; analyze the distribution of psychotropics according to their presence on the Relação Nacional de Medicamentos Essenciais (RENAME [National List of Essential Medicines]) and acquisition according to the source of funding (free of charge or direct payment); and estimate the proportion of free-of-charge psychotropic drugs according to therapeutic class and presence on the RENAME. This study involved the analysis of data from the 2014 National Survey on the Accessibility, Use and Promotion of the Rational Use of Medicines considering psychotropic drugs used by the adult population (≥20 years; n = 32,348). The prevalence of the acquisition of free-of-charge psychotropic drugs was 53.3% and 64.6% of these drugs were on the RENAME. Among the psychotropic drugs acquired by direct payment, 70.8% were not on the national list. Regarding free-of-charge acquisition according to the therapeutic class and presence on the RENAME, differences were found for antidepressants, anxiolytics and antipsychotics (p <0.05). In conclusion, the most used psychotropic medicines were listed in the RENAME, but free-of-charge acquisition was not provided for all of them

Availability of essential medicines in primary health care of the Brazilian Unified Health System.

OBJECTIVE: To characterize the availability of tracer medicines in pharmaceutical services in primary health care of the Brazilian Unified Health System (SUS). METHODS: This is a cross-sectional and evaluative study, part of the Pesquisa Nacional Sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos - Serviços, 2015 (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines - Services, 2015). To analyze the availability of medicines, we verified 50 items selected from the Relação Nacional de Medicamentos Essenciais (Rename - National List of Essential Medicines) of 2012. Observation scripts were applied to medicine dispensing services in the primary health care. Interviews were carried out with patients, health care professionals, and public managers, using semi-structured questionnaires. The availability index was presented as the percentage of health units where the medicines were available. For statistical analysis, absolute, relative, and mean frequencies were presented (with 95% confidence intervals). The comparison of groups was carried out by Pearson Chi-square tests or variance analysis, when needed. RESULTS: One thousand, one hundred, and seventy-five observation scripts were filled in a national representative sample composed by 273 cities. Statistically significant differences were observed regarding the type of unit, infrastructure, and presence of a pharmacist between regions of Brazil. The average availability of tracer medicines in primary health care was 52.9%, with differences between regions and sampling strata. This index increased to 62.5% when phytotherapic medicines were excluded. We found limited availability of medicines for treatment of chronic and epidemiological diseases, such as tuberculosis and congenital syphilis. CONCLUSIONS: The low availability of essential medicines purchased centrally by the Brazilian Ministry of Health indicates deficiencies in supply chain management. The different views on the availability of tracer medicines in SUS confirm the general availability verified in this study. Among patients, about 60% said they obtain medicines in SUS units, data consistent with the lack of medicines reported by medicine dispensers and in line with physicians' evaluations.

Characterization of the selection of medicines for the Brazilian primary health care.

OBJECTIVE: To characterize the process of selection of medicines for primary health care in the Brazilian regions. METHODS: This article is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos - Serviços, 2015 (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines - Services, 2015), a cross-sectional study that consisted of an information gathering in a sample of cities in the five regions of Brazil. The data used were collected by interviews with those responsible for pharmaceutical services (PS) (n = 506), professionals responsible for the dispensing of medicines (n = 1,139), and physicians (n = 1,558). To evaluate the difference between ratios, we adopted the Chi-square test for complex samples. The differences between the averages were analyzed in generalized linear models with F-test with Bonferroni correction for multiple comparisons. The analyses considered significant had p≤0.05. RESULTS: The professionals responsible for pharmaceutical services reported non-existence of a formally constituted Pharmacy and Therapeutics Committee (PTC) (12.5%). They claimed to have an updated (80.4%) list of Essential Medicines (85.3%) and being active participants of this process (88.2%). However, in the perception of respondents, the list only partially (70.1%) meets the health demands. Of the interviewed professionals responsible for the dispensing of medicines, only 16.6% were pharmacists; even so, 47.8% reported to know the procedures to change the list. From the perspective of most of these professionals (70.9%), the list meets the health demands of the city. Among physicians, only 27.2% reported to know the procedures to change the list, but 76.5% would have some claim to change it. Most of them reported to base their claims in clinical experiences (80.0%). For 13.0% of them, the list meets the health demands. CONCLUSIONS: As this is the first national survey of characterization of the process of selection of medicines within primary health care, it brings unpublished data for the assessment of policies related to medicines in Brazil.

A survey on the extent of medication storage and wastage in urban Iranian households.

BACKGROUND: Prescription and nonprescription medications constitute a substantial proportion of the health care costs of countries. National drug policies and attitudes toward medication use may play a role in irrational prescribing and consumption of medicines, leading to drug wastage. The limited resources of developing countries warrant more careful assessments of current national drug policies. OBJECTIVE: This study quantified the amounts and types of medications that are stored in a sample of urban Iranian households and estimated the extent of drug wastage in these families. METHODS: A literature search was conducted using MEDLINE and International Pharmaceutical Abstracts for 1966 to 2004 to identify articles on drug utilization and wastage. Randomly selected households in a large city in Iran were visited to determine the amounts and types of medicines stored in these households. A questionnaire was used to collect information about medication use in these families. RESULTS: A total of 512 households were assessed. The mean (SD) family size of household respondents was 4.3 (1.6) members. Mothers were responsible for managing medications in 58.1% (291/501) of families. Presence of chronic illness, insurance coverage, higher economic status, literacy among fathers, and siblings without medically related jobs were the variables that showed a significant relationship with the amount of medicines found in the households. The mean (SD) numbers of unit doses of medicines and of drug products found in these households were 238.5 (198.6) and 22.99 (20.1), respectively. The most common therapeutic classes of medications kept at home were central nervous system agents, anti-infectives, and gastrointestinal medications. The real and potential medication wastage was estimated to be 38.8% and 53.8%, respectively. CONCLUSIONS: Medications were stored in large quantities in these urban Iranian households, and a large percentage was being wasted. Drug-use assessments and a comprehensive evaluation of the current national drug policies are warranted to curtail this problem.

Aplicación del Sistema de Clasificación Biofarmacéutica al Cuadro Básico de Medicamentos de Cuba: ¿bioequivalencia in vivo o disolución in vitro? / Application of the Biopharmaceutical Classification System to the Basic Table of Medicines of Cuba: bioequivalence in vivo or dissolution in vitro?

El siguiente trabajo tiene como objetivos clasificar los ingredientes farmacéuticos activos (IFAs) de los sólidos orales de liberación inmediata del Cuadro Básico de Medicamentos de Cuba (CBM) que son producidos nacionalmente, según el Sistema de Clasificación Biofarmacéutica (SCB), y proponer aquellos que podrían demostrar su intercambiabilidad terapéutica a través de ensayos de disolución in vitro. Para ello se utilizó el listado de medicamentos del CBM de Cuba del 2019 y se realiza una clasificación biofarmacéutica provisional consenso, a partir de diferentes clasificaciones biofarmacéuticas publicadas y de una extensiva revisión de la literatura. Se identificó que aproximadamente el 48% de los IFAs del CBM presentan polimorfismo y que el 12,3% de las formas sólidas orales del CBM de Cuba tienen un estrecho margen terapéutico, por lo que no pueden ser bioexonerados mediante estudios de bioequivalencia in vitro basados en el SCB. Se constató que un 50,8% de los IFAs de formas sólidas orales de liberación inmediata del CBM de Cuba han sido clasificados según el SCB por la OMS. La aplicación conjunta de diversas metodologías de clasificación biofarmacéutica permitió clasificar provisionalmente todos los IFAs de las formas sólidas orales del CBM, demostrando que el 66,1% pertenece a las clases I, III y I/III del SCB, por lo que podrían ser bioexonerados de ensayos de bioequivalencia in vivo en humanos

The goals of the present work are to classify the active pharmaceutical ingredients (APIs) of the oral solids of immediate release of the Essential List of Medicines of Cuba (CBM) that are produced nationally, according to the Biopharmaceutical Classification System (BCS), and to propose those that could demonstrate their therapeutic interchangeability through in vitro dissolution tests. For this was used the Cuban CBM drug list of 2019, and a provisional consensus biopharmaceutical classification is proposed, based on different published biopharmaceutical classifications and an extensive review of the literature. It was identified that approximately 48% of the CBM IFAs present polymorphism and that 12.3% of the oral solid forms of CBM in Cuba have a narrow therapeutic margin, for which reason they cannot be bioexonerated through in vitro bioequivalence studies based on BCS. It was found that 50.8% of the oral solid forms of CBM in Cuba have been classified according to SCB by WHO. The joint application of diverse methodologies of biopharmaceutical classification allowed to provisionally classify all the IFAs of the oral solid forms of CBM, demonstrating that 66.1% belongs to classes I, III and I/III of the SCB, reason why they could be biowaivered from in vivo bioequivalence assays in humans

[The list of drugs in the Popular Pharmacy Program and the Brazilian National Pharmaceutical Care Policy]. / Elenco de medicamentos do Programa Farmácia Popular do Brasil e a Política de Nacional Assistência Farmacêutica.

This study aimed to analyze the list of drugs in the Popular Pharmacy Program in Brazil (PFPB) in relation to the country's pharmaceutical care policy. The list of drugs in the PFPB was compared to the Brazilian and international reference lists of essential medicines, the components of pharmaceutical care in Brazilian Unified National Health System (SUS), and drug production by the country's government pharmaceutical laboratories. The PFPB list includes 119 drugs, of which 19.3% and 47.1% were not selected on the Brazilian and international reference lists, respectively; 16.8% are not used in primary care, and 40.3% are not produced by the country's government laboratories. A revision of the PFPB list based on the essential medicines concept (World Health Organization), alignment of pharmaceutical care policies, and production by government laboratories are essential to improve quality of health care, management, training of prescribers, and information for the population.

Availability of medicines in public sector health facilities of two North Indian States.

BACKGROUND: Access to free essential medicines is a critical component of universal health coverage. However availability of essential medicines is poor in India with more than two-third of the people having limited or no access. This has pushed up private out-of-pocket expenditure due to medicines. The states of Punjab and Haryana are in the process of institutionalizing drug procurement models to provide uninterrupted access to essential medicines free of cost in all public hospitals and health centres. We undertook this study to assess the availability of medicines in public sector health facilities in the 2 states. Secondly, we also ascertained the quality of storage and inventory management systems in health facilities. METHODS: The present study was carried out in 80 public health facilities across 12 districts in Haryana and Punjab states. Overall, within each state 1 MC, 6 DHs, 11 CHCs and 22 PHCs were selected for the study. Drug procurement mechanisms in both the states were studied through document reviews and in-depth interviews with key stakeholders. Stock registers were reviewed to collect data on availability of a basket of essential medicines -92 at Primary Health Centre (PHC) level, 132 at Community Health Centre (CHC) level and 160 at tertiary care (District Hospital/Medical College) level. These essential medicines were selected based on the Essential Medicine List (EML) of the Department of Health (DOH). RESULTS: Overall availability of medicines was 45.2% and 51.1% in Punjab and Haryana respectively. Availability of anti-hypertensives was around 60% in both the states whereas for anti-diabetics it was 44% and 47% in Punjab and Haryana respectively. Atleast one drug in each of the categories including analgesic/antipyretic, anti-helminthic, anti-spasmodic, anti-emetic, anti-hypertensive and uterotonics were nearly universally available in public sector facilities. On the contrary, medicines such as thrombolytics, anti-cancer and endocrine medicines were available in less than 30% in public sector facilities. Among the medicines which were not available at the time of survey in Haryana, nearly 60% of them were out of stock for 3-6 months whereas 8% of them were out of stock for more than 6 months. CONCLUSION: Health system needs to be strengthened by making essential medicines available for patients. Ensuring access to free medicines is likely to reduce private expenditure on medicines, which is a long-term, sustainable way to towards universal health coverage in India.