WHO Model List Research Articles

Drug utilization pattern of analgesics in various departments of a tertiary care teaching rural dental hospital

Background: The aim was to study drug utilization pattern of analgesics in various departments of a tertiary care teaching rural dental hospital. Methods: A prospective and observational study was undertaken in 150 patients from January 2014 to February 2014. Relevant information was obtained from the interview as well the hospital case record. Structured and pre-tested format were used for compiling the data. Results: The majority of the patients (46%) were in the age group 41-60 years. Common indications for analgesic use included endodontic diseases (61.3%), surgical procedures (41.33%), and periodontal diseases (27.33%). Three analgesic formulations were used leading to a total of 150 drug uses. Fixed-dose drug combination (FDC) of diclofenac sodium plus paracetamol (78.66%) was the most commonly prescribed analgesic formulation, followed by aceclofenac plus paracetamol (15.33%) and ibuprofen (6%). The average number of analgesics prescribed per patient was 1.94. Analgesics were prescribed for 3 days. Except ibuprofen, FDC of diclofenac sodium + paracetamol and aceclofenac + paracetamol have been included in the WHO model list of essential medicines. All analgesic drug formulations were prescribed by their brand names. Conclusions: Drug utilization data can help to formulate appropriate clinical guidelines for drug use and facilitate rational use of medicines in population.

Research and development for neglected diseases: more is still needed, and faster.

Research and development for neglected diseases: more is still needed, and faster.

Purely in Silico BCS Classification: Science Based Quality Standards for the World’s Drugs

BCS classification is a vital tool in the development of both generic and innovative drug products. The purpose of this work was to provisionally classify the world's top selling oral drugs according to the BCS, using in silico methods. Three different in silico methods were examined: the well-established group contribution (CLogP) and atom contribution (ALogP) methods, and a new method based solely on the molecular formula and element contribution (KLogP). Metoprolol was used as the benchmark for the low/high permeability class boundary. Solubility was estimated in silico using a thermodynamic equation that relies on the partition coefficient and melting point. The validity of each method was affirmed by comparison to reference data and literature. We then used each method to provisionally classify the orally administered, IR drug products found in the WHO Model list of Essential Medicines, and the top-selling oral drug products in the United States (US), Great Britain (GB), Spain (ES), Israel (IL), Japan (JP), and South Korea (KR). A combined list of 363 drugs was compiled from the various lists, and 257 drugs were classified using the different in silico permeability methods and literature solubility data, as well as BDDCS classification. Lastly, we calculated the solubility values for 185 drugs from the combined set using in silico approach. Permeability classification with the different in silico methods was correct for 69-72.4% of the 29 reference drugs with known human jejunal permeability, and for 84.6-92.9% of the 14 FDA reference drugs in the set. The correlations (r(2)) between experimental log P values of 154 drugs and their CLogP, ALogP and KLogP were 0.97, 0.82 and 0.71, respectively. The different in silico permeability methods produced comparable results: 30-34% of the US, GB, ES and IL top selling drugs were class 1, 27-36.4% were class 2, 22-25.5% were class 3, and 5.46-14% were class 4 drugs, while ∼8% could not be classified. The WHO list included significantly less class 1 and more class 3 drugs in comparison to the countries' lists, probably due to differences in commonly used drugs in developing vs industrial countries. BDDCS classified more drugs as class 1 compared to in silico BCS, likely due to the more lax benchmark for metabolism (70%), in comparison to the strict permeability benchmark (metoprolol). For 185 out of the 363 drugs, in silico solubility values were calculated, and successfully matched the literature solubility data. In conclusion, relatively simple in silico methods can be used to estimate both permeability and solubility. While CLogP produced the best correlation to experimental values, even KLogP, the most simplified in silico method that is based on molecular formula with no knowledge of molecular structure, produced comparable BCS classification to the sophisticated methods. This KLogP, when combined with a mean melting point and estimated dose, can be used to provisionally classify potential drugs from just molecular formula, even before synthesis. 49-59% of the world's top-selling drugs are highly soluble (class 1 and class 3), and are therefore candidates for waivers of in vivo bioequivalence studies. For these drugs, the replacement of expensive human studies with affordable in vitro dissolution tests would ensure their bioequivalence, and encourage the development and availability of generic drug products in both industrial and developing countries.

Prescription Analysis of Drugs Prescribed For Children in Some Towns of Maharashtra

Objective: To analyze the drug prescibed for the children in some towns of Maharashtra with reference to WHO Essential Drug List for Children, March 2011. Method: Data for this study collected by II MBBS students at their home towns like Jalna, Solapur and Chipulun with the help of prescription analysis form prepared by Department of Pharmacology. Rationality of prescription was evaluated as per WHO Model List for Essential Drugs for Children (2011). Results: Total 46 prescriptions of issued for children in Jalna, Solapur and Chiplun were analyzed. 31.48 % drugs prescribed for children in these towns were according WHO list of Essential Drugs for Children. Out of total 108 drugs prescribed 39.81 % were FDCs. 27.91% prescribed FDCs were rational. FDCs prescribed in this study were mainly from drug groups like antibiotics (25.58 %), vitamins/minerals (23.26 %), cough /cold (27.91 %) and analgesics (18.60 %) FDCs. Rational FDCs prescribed in this study were from the class of antibiotics. Conclusions: More than 68% prescribed drug for children in towns are not in accordance with WHO Model List of Essential Drugs for Children. Interventions to rectify over prescription of antimicrobials and cough/cold FDCs in children are needed. Vitamins/Minerals FDCs many times only add to the expenditure bill of the patient without giving any potential benefit. Vitamins and Minerals FDCs prescription should be based on deficiency status. Making availability of WHO/National Essential Drug List for children to all the prescribing physicians and organizing regular workshop/ educational campaign for rational prescribing may help in this regard.

Progressive Applications of Dissolution, Its Impact, and Implications in the Pharmaceutical World

Progressive Applications of Dissolution, Its Impact, and Implications in the Pharmaceutical World

Time to include buprenorphine-naloxone combination in the WHO model list of essential medicines

No abstract

The who concept of essential medicines and the who ethical criteria for medicinal drug promotion: history and lessons for domestic pharmaceutical sector

The review covers the history and evolution of the WHO initiatives in pharmaceutical policy - for better and safer use of medicines, their scientifically based selection and ethical promotion. The WHO Concept of Essential Medicines, the WHO vision of the Rational Use of medicines and the WHO Ethical Criteria for Medicinal Drug Promotion are reviewed. Contribution of these WHO designed initiatives, definitions and documents to Global Health, particularly relating to modern Russian health system problems is discussed. The principles and methodology of drug selection are presented. The review describes health system benefits of the WHO Essential Medicines Concept implementation at a national level. Advantages of the WHO Model List of Essential Medicines use not only as a model product, but as a model process and an healthcare instrument are emphasized. The WHO principles of the Rational Use of Medicines, the history of its International development, the WHO key strategies towards the Rational Use of Medicines and the major barriers on the way are described. The history of the WHO Ethical Criteria for medicinal drug promotion development is presented in line with the basic principles and objectives of this unique international document. The core goal of the WHO Ethical Criteria is to improve health and healthcare through the rational use of medicines. The global implementation of the WHO Essential Medicines Concept and the ever growing barriers to the rational use of medicines and advances in public health, as well the advances and problems of the Russian national health system, are discussed in the historical perspective.

Evaluation of prescribing patterns of teaching and non teaching hospitals by undergraduate medical students in Pune, India

Background : This study was carried out in various hospitals to analyze the use of rational fixed dose combinations (FDCs) in Pune. Methods : 279 prescriptions were evaluated in this study. Information about age, sex, names of the all the drugs prescribed by doctor/ physician, diagnosis for the use of prescriptions and adverse effects were noted in the audit form from the prescriptions of the patients. Rationality of fixed dose combination is evaluated according to WHO Model List of Essential Drugs, 17th updated version, 2011. Results : 56.98 % doctor’s prescriptions in this study were containing of fixed dose combinations and out of this 10.69 % prescriptions were including two or more FDCs in their prescriptions. Only 13.20% FDCs were in accordance with WHO Model List of Essential Drugs. FDCs from antiinflammatory and antirheumatic products, vitamins, minerals, antianaemic preparations, drugs for acid related disorders, antibacterials for systemic use and cough and cold preparations were used more by private non teaching hospitals as compared to SKNMC & GH teaching hospital. 64.61 % prescriptions of private hospitals and 34.08 % prescriptions of teaching hospital were containing more than one drug. Conclusions : This study has shown that about every alternate prescription contains FDC. More than 80 % of prescribed FDCs are not in accordance with Essential Drugs List. Vitamins, minerals, antianaemic preparation FDCs should be prescribed judiciously as they are not free from ADRs. More number of drugs (poly-pharmacy) and FDCs were prescribed by non teaching private hospitals.

Availability of Pediatric Medicines and their Perception among Prescribers at a Tertiary Care Teaching Hospital

The pediatric population is heterogeneous group with markedly different pharmacokinetics from that in adults. However, conventionally adult dosage forms are fragmented to treat pediatric patients due to the poor availability of child friendly formulations in public health facilities. An observational, cross-sectional study was undertaken at pharmacy store and pediatric department at a tertiary care hospital. Each medicine with dosage form and strength was listed separately and compared with WHO Model List of Essential Medicines for Children (EMLc), Key tracer and Priority medicines for children. Prescribers were also interviewed using a validated structured questionnaire. Out of 27 drug groups listed in WHO EMLc, a large deficiency was observed in chemotherapeutics (47%), gastrointestinal (50%) and ophthalmic preparations (100%). Out of total 258 paediatric medicines, 55.8% were available. A gross deficiency of child specific dosage formulations was also observed. Majority (91%) of the prescriber confessed of using fragmented adult formulations and experienced drug administration problem. The availability of paediatric medicines in appropriate dosage formulations and strength is not satisfactory at public health facilities. Pharmacologically, children are separate group and their need should be addressed by including child friendly formulations in EML or having separate EMLc.

Current scenario of rational usage of various drugs in indoor patients

Background: Irrational prescribing of drugs is of common occurrence in clinical practice. Rational drug prescribing is defined as “the use of the least number of drugs to obtain the best possible effects in the shortest period and at a reasonable cost”. The present study was designed to evaluate the practice of rational prescription in patients (cases) admitted in various wards ofG.S.V.M.MedicalCollege and associated hospitals atKanpur. Methods: This study was carried out on patients admitted in different wards. For the study of drug prescribing patterns, each prescribed drug was counted only once for a patient, irrespective of change in dose and route of administration. WHO guidelines were taken into consideration. Both distribution of type of drug as well as drug category were evaluated in different departments thereafter. The characteristics chosen on each prescription provided the incidence of poly pharmacy and frequencies of prescribing of individual drug were analyzed. The data obtained were subsequently categorized systematically and analyzed by taking WHO guidelines into consideration. Results: The most commonly prescribed drugs were vitamins and tonics (57.5%) followed by anti-microbial agents (12.7%), non-steroidal anti-inflammatory drugs (10.5%), anti-hypertensive (5.2%), anti cough remedies and acid peptic disease drugs. Generic drug prescription was very low as most of drugs prescribed were proprietary. A low number of Fixed Dose Combinations (FDCs) were prescribed, this finding was in accordance with the WHO recommended list of FDCs. Items on the WHO model list of essential drugs were prescribed frequently. The use of drugs has been found to be in accordance with the disease, the patient had. Conclusions: Present study highlighted that there was a high incidence of irrational prescribing practice that increased with the total number of drugs per prescription.

Evaluation of In Vitro Equivalence for Tablets Containing the Poorly WaterSoluble Compound Atorvastatin

This paper describes the evaluation of the in vitro equivalence of tablets containing a poorly water-soluble compound, atorvastatin, marketed in Bangladesh under biowaiver conditions. Drug release was compared with that of a reference product. The in vitro equivalence test was carried out in three different media (pH 1.2, pH 4.5, and pH 6.8). Test results were subjected to statistical analysis to compare the dissolution profiles. Model-independent approaches of difference factor (f1), similarity factor (f2), and dissolution efficiency (%DE) were employed. Dissolution profiles of test and reference (innovator) atorvastatin are equivalent at pH 6.8 without statistical treatment. The test products are equivalent at pH 4.5 (f1 50) and not equivalent at pH 1.2 (f1 > 15 and f2 < 50). Other general quality parameters of these tablets (e.g., weight variation, crushing strength, friability, and disintegration time) were also determined according to established protocols, and test results were within limit. INTRODUCTION Some drugs that have a good clinical therapeutic effect often show low systemic availability because of poor water solubility. Up to 40 percent of new chemical entities discovered by the pharmaceutical industry today are poorly soluble or lipophilic compounds. The solubility issues complicate the delivery of these new drugs and many existing drugs (1). Poorly water-soluble drugs show unpredictable absorption and high intrasubject and intersubject variability (2–4). Therefore, constant surveillance of marketed, poorly water-soluble drugs by the government, manufacturers, and independent research groups is essential to ensure availability of quality medicines. Atorvastatin, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMGCoA) reductase, which catalyzes the conversion of HMG-CoA to mevalonate, an early rate-limiting step in cholesterol biosynthesis (5). The calcium salt of atorvastatin is currently used for the treatment of hypercholesterolemia (6). The intestinal permeability of atorvastatin is high at the physiologically relevant intestinal pH (7, 8). However, it has been reported that the absolute bioavailability of atorvastatin is only 12% after a 40-mg oral dose (9). The low systemic availability is attributed to low dissolution, presystemic clearance in gastrointestinal mucosa, and hepatic first-pass metabolism (10). Atorvastatin calcium is a crystalline powder and is insoluble in aqueous solution at pH 4 and below. It is very slightly soluble in water. The solubility in aqueous solution at pH 2.1 is about 0.0204 mg /mL, while the solubility in pH 6.0 aqueous solution is about 1.23mg/mL (11). The dose/ solubility (D/S) ratio for atorvastatin is greater than 250 mL for the 10-mg dose at pH 1.2, although the drug dissolves in 250 mL of buffer solution at pH 6.8. Therefore, atorvastatin is a low solubility drug according to WHO Guidance (12). Atorvastatin is not listed in the WHO Model list and is not classified according to BCS by WHO (13). Because of its solubility (low) and permeability (high), atorvastatin is assigned to BCS Class 2 according to WHO guidance. We selected atorvastatin tablets to evaluate the quality of locally available, lipid-lowering drugs with special emphasis on the study of disintegration and dissolution properties of the test samples due to their immense importance in predicting drug bioavailability as well as product quality. We used USP buffer solutions of pH 1.2 (hydrochloric acid solution), pH 4.5 (acetate buffer solution), and pH 6.8 (phosphate buffer solution). Six units were tested for dissolution. Other general quality parameters of these tablets like weight variation, crushing strength, friability, disintegration time were also determined according to established protocols. The test results were subjected to statistical analysis to compare the dissolution profile. Model independent approaches of difference factor (f1), similarity factor (f2), and dissolution efficiency (%DE) were employed. MATERIALS AND METHODS Chemicals Standard atorvastatin calcium was a kind gift from Incepta Pharmaceuticals Ltd., Bangladesh. Three brands *Corresponding author. e-mail: ashraf@uap-bd.edu dx.doi.org/10.14227/DT190412P30

A public-health approach to site-specific formulary management: addressing deficient drug supplies in Malawi†

Maintaining a well-stocked dispensary at a private non-profit clinic in a developing country can often be challenging due to limited financial and human resources. Organizations face frequent drug shortages, excesses of unnecessary medications and potentially inappropriate international donations. To promote adherence to international recommendations and enable targeted requests for international drug donations, this paper describes a process using a public-health approach to create a site-specific pharmacy formulary in a resource-poor setting using the World Health Organization's (WHO) Model List of Essential Medicines ('Model List'). The study site was a Malawian-run non-profit private clinic serving over 3000 people annually. The organization focuses on providing community support for orphans from the HIV/AIDS crisis in sub-Saharan Africa. While using the Model List as a backbone, we incorporated the clinic's drug inventory, patient needs, clinician prescribing patterns, and the country's national drug list into the final formulary. After analyzing site-specific factors, we determined which WHO Model List therapeutic classes were necessary for the clinic to address in the final formulary. Of the drug products currently available in the inventory, 65.6% were expired, 29.8% of which were international donations. After removing expired medications from the inventory, seven Model List priority categories remained unaddressed by the clinic's initial inventory. Based on the results of a structured needs assessment, 54 products were selected for the final simplified formulary. Conscious selection of pharmaceuticals, resulting in a systematic formulary for drug distribution management, is critical so that a clinic can focus on procuring and prescribing the most needed medications. This selection process using the WHO Model List and a public-health approach to drug management could serve as a private clinic model for pharmaceutical optimization and targeted international drug donations in sub-Saharan Africa and other resource limited settings.

A Proposed Framework for Formulary Listing in Low-Income Countries

Formularies of reimbursed drugs are widely adopted tools in healthcare systems. However, little is known about the selection process of drugs that appear on these formularies. The aim of this paper was to shed light on this process by reviewing the way selected public Drug Benefit Plans in high-, middle- and low-income countries, including Canada, the US, UK, France, Germany, Brazil, South Korea and Ghana, manage the formulary listing process. Common steps and challenges are identified and this information used to make recommendations for developing a framework for formulary listing in low-income countries. We found that all DBPs studied used a formulary to list reimbursable drugs and the selection criteria utilized to determine which drugs should be listed were similar between plans, although weighting of individual criterion differs and the composition of the committee (i.e. physician vs economist) is likely to have an impact. The WHO model list of essential medicines plays a bigger role in formulary selection in middle-income countries than in high-income countries. In low-income countries, the focus is on the prioritization of health interventions and improving access to healthcare. On the basis of our review and an appraisal of the health needs of low-income countries, we have proposed four steps that are the pillars of our framework for formulary conception in low-income countries. These steps are the identification and weighting of relevant formulary listing criteria (combining both literature review and qualitative research approaches), the determination of priority diagnostics/treatments to be assessed, the criteria scoring and the treatment ranking by priority order of reimbursement. Finally, for the purpose of developing a formulary, we recommend use of the multicriteria decision analysis approach to guide priority drug ranking.

Two Atypical l-Cysteine-regulated NADPH-dependent Oxidoreductases Involved in Redox Maintenance, l-Cystine and Iron Reduction, and Metronidazole Activation in the Enteric Protozoan Entamoeba histolytica

We discovered novel catalytic activities of two atypical NADPH-dependent oxidoreductases (EhNO1/2) from the enteric protozoan parasite Entamoeba histolytica. EhNO1/2 were previously annotated as the small subunit of glutamate synthase (glutamine:2-oxoglutarate amidotransferase) based on similarity to authentic bacterial homologs. As E. histolytica lacks the large subunit of glutamate synthase, EhNO1/2 were presumed to play an unknown role other than glutamine/glutamate conversion. Transcriptomic and quantitative reverse PCR analyses revealed that supplementation or deprivation of extracellular L-cysteine caused dramatic up- or down-regulation, respectively, of EhNO2, but not EhNO1 expression. Biochemical analysis showed that these FAD- and 2[4Fe-4S]-containing enzymes do not act as glutamate synthases, a conclusion which was supported by phylogenetic analyses. Rather, they catalyze the NADPH-dependent reduction of oxygen to hydrogen peroxide and L-cystine to L-cysteine and also function as ferric and ferredoxin-NADP(+) reductases. EhNO1/2 showed notable differences in substrate specificity and catalytic efficiency; EhNO1 had lower K(m) and higher k(cat)/K(m) values for ferric ion and ferredoxin than EhNO2, whereas EhNO2 preferred L-cystine as a substrate. In accordance with these properties, only EhNO1 was observed to physically interact with intrinsic ferredoxin. Interestingly, EhNO1/2 also reduced metronidazole, and E. histolytica transformants overexpressing either of these proteins were more sensitive to metronidazole, suggesting that EhNO1/2 are targets of this anti-amebic drug. To date, this is the first report to demonstrate that small subunit-like proteins of glutamate synthase could play an important role in redox maintenance, L-cysteine/L-cystine homeostasis, iron reduction, and the activation of metronidazole.

IVH – The rise (and fall) of the surfactant dose?

The incidence (or not) of intraventricular haemorrhage (IVH) in infants receiving surfactant remains controversial. Moreover, it is well known that the incidence of IVH, adjusted for known risk factors, varies across neonatal intensive care units (NICUs) in any country. Given that a trend towards an increase in overall IVH incidence with natural surfactant was noted in the meta-analysis by Soll, an important question arises: Could a recent trend in higher concentrations/doses of natural surfactant lead to an increase in IVH? It is not suggested that there is a consistent association between surfactant treatment and IVH, but this is an interesting consideration. As surfactant treatment has consistently been shown to lower mortality, it is extremely important to ensure that this is not at the expense of increased survival of infants brain damaged by haemorrhage or ischaemia. Infants who present with respiratory distress syndrome (RDS) are extremely vulnerable, and are precisely the infants most at risk of cerebral lesions. This relevant question is applicable in South Africa and internationally, with the proposal for the inclusion of surfactant in the WHO model list of essential medicines. Since surfactant has been adopted into routine neonatal practice in South Africa, the other very important question of economic impact has shifted to questions regarding the specific preparations, number of doses, modes of administration, concomitant use of new technologies such as nasal continuous pulmonary airway pressure (nCPAP), etc. However, before stakeholders plunge headlong into an economic – or any other – argument, perhaps there is a need for greater collaboration between clinicians (and the pharmaceutical industry) in the reporting of recent trends, including adverse events in this very vulnerable group.

In Vitro Dissolution Kinetics of Amlodipine Tablets Marketed in Russia Under Biowaiver Conditions

The current paper is devoted to in vitro dissolution kinetics studies of amlodipine tablets marketed in Russia under biowaiver conditions. Dissolution kinetics studies were carried out according to WHO Guidance. Dissolution profiles of test and reference (innovator) amlodipine tablets were considered equivalent. INTRODUCTION Over the past three decades, dissolution testing has evolved into a powerful tool for characterizing the quality of oral pharmaceutical products. For some solid dosage forms containing active pharmaceutical ingredients with special properties, a comparative in vitro dissolution profile similarity can be used to establish equivalence of test with reference product. Such studies, used to approve equivalence other than through in vivo equivalence testing, are called “biowaiver” (1). Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. It is indicated for the treatment of hypertension, chronic stable angina, and confirmed or suspected vasospastic angina (2). The chemical name of amlodipine is 3-ethyl 5-methyl 2-[(2aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4dihydropyridine-3,5-dicarboxylate. Its structure is shown in Figure 1. Solubility Amlodipine is described as slightly soluble in water in different Pharmacopoeias (3, 4). The experimental water solubility for amlodipine is 75.3 mg/L (5). The lowest solubility in the pH range from 1 to 6.8 at 37 °C is 1 mg/mL (1). Within the gastrointestinal pH range, amlodipine is an ionized compound (weak base) (5). The pKa of amlodipine is about 8.6 at 25 °C (5). Dosage form strength is expressed in mg of salt and is not equivalent to the free base. Amlodipine is listed in the WHO Model list of medicines as an antihypertensive medicine in a 5-mg tablet strength (6). Russia has Marketing Authorizations for amlodipine as an immediate-release dosage form in strengths of 2.5; 5, and 10 mg (7). Thus the D/S ratio for the amlodipine WHO Model List of Essential Medicines dose (5 mg) at a pH range of 1.2–6.8 is 5 mL and 10 mL for the highest dose marketed in Russia. Therefore, amlodipine is a “highly soluble” drug according to WHO Guidance (D/S ratio ≤ 250 mL). Permeability When an active pharmaceutical ingredient is absorbed to an extent of 85% or more, it is considered “highly permeable.” Amlodipine’s absolute bioavailability is 60–65%, but its permeability is classified as “high” due to metabolite excretion in urine (90–95%). Taking amlodipine solubility and permeability into account, according to WHO Guidances, amlodipine is assigned to BCS Class I (1). Thus, amlodipine in vitro equivalence may be evaluated under biowaiver conditions for BCS Class I (1). MATERIALS AND METHODS Chemicals Analytical grade concentrated hydrochloric acid, glacial acetic acid, potassium dihydrophosphate, disodium hydrophosphate dodecahydrate, and potassium chloride were used. e-mail: ramenskaia@mail.ru *Corresponding author. Figure 1. Structure of amlodipine. diss-17-03-04.indd 20 8/18/2010 1:42:43 PM dx.doi.org/10.14227/DT170310P20

A comparative analysis of the Libyan national essential medicines list and the WHO model list of essential medicines

Aim and Objectives: To examine the concordance of the Libyan Pharmaceutical List of Essential Medicines (LPLEM) with the World Health Organization Model List of Essential Medicines 2009 (WMLEM 2009).Methods: The concordance between generic medicines listed in the WMLEM 2009 (standard reference list) and the LPLEM 2006 (comparator list) was evaluated.Results: The total number of Basic Essential Medicines (BEMs) listed on the WMLEM 2009 was 347. The total number of generic medicines listed on the LPLEM was 584. Although the LPLEM has more listed medicines, only 270 (77.6%) of BEMs from the WMLEM were listed as available. However, 25 of the 77 missing medicines were deemed to have appropriate alternatives. A total of 52 medicines from the WMLEM 2009 were therefore missing from the LPLEM. Discrepancies compared to the WMLEM 2009 were identified in 15 out of 29 therapeutic sections. The highest discrepancy rate from the WMLEM 2009 was in the anti-infective section (35 missing medicines). Missing BEMs were noted in many subclassifications of the anti-infective medicines section, but omissions were particularly prevalent in the antibacterial medicines subsection (11 missing medicines). Antituberculosis medications had the highest discrepancy rate for antibacterial BEMs with one-third of the single medicines recommended by the WHO in the WMLEM 2009 not listed on the LPLEM. Of the 314 additional medicines on the LPLEM, 18 were deemed to be irrational non-essential medicines.Conclusion: The LPLEM does not include several essential medicines recommended by the WHO in the WMLEM 2009. These discrepancies may have serious public health implications for management of some infectious diseases, particularly, tuberculosis and HIV.

Number comparison of medicines lists effective in the Republic of Tatarstan with the WHO model list of essential medicines: Do numbers matter?

A comparative analysis of positive medicines lists effective in the Republic of Tatarstan in 2009 was carried out to identify problems with development and functioning of 4 different lists. Comparison of listed medicine numbers revealed the extent of discrepancies requiring policy action. The discrepancies were uniform through the lists and reflected vulnerability to pharmaceutical promotion. It was concluded that development of national pharmaceutical policy was urgently needed to further implement the WHO Essential Medicines Concept.

Improving availability and affordability of plasma-derived medicines

Plasma contains several therapeutically important proteins. Currently more than 25 of them are commercially available to treat life-threatening diseases. Some of these medicines already included in the WHO Model List of Essential Medicines indicating their importance from a global perspective. However, unfortunately due to very high cost of treatment with plasma-derived medicines, these clinically precious tools are not affordable for a majority of the patients living in developing countries. There are some options available for securing accessibility to these medicines. These include local production, importation and contract fractionation of locally produced plasma. Although local production of plasma-derived medicines and/or importation of these medicines might be a practical approach to respond to the needs for these medicines, in recent years several countries have used contract fractionation of locally produced plasma as a very effective approach for improving availability and affordability of plasma-derived medicines in their national market.

Adding a Medicine to the WHO Model List of Essential Medicines

Although the concept of essential medicines is not new, the processes that lead to placement of these medicines on the World Health Organization Model List of Essential Medicines are not well understood. Here, we describe the process by which we added a class of drugs, statins, to the Model List to help combat the growing global epidemic of cardiovascular disease.