What Factors Hindered the Access to Essential Anticancer Medicine in Public Hospitals for the Local Population in Hubei Province, China

Background:Cancer poses a serious threat to one’s health, which caused significant economic burden on the family and society. Poor availability and affordability resulted in some essential medicines failing to meet the basic health needs of this group of patients. The objective of this study was to evaluate the availability, prices and affordability of 32 anticancer essential medicines in Hubei Province, China.Methods: Data on the availability and price related information of 32 essential anticancer medicines in the capital and five other cities of Hubei Province were collected. A total of 28 hospitals were sampled, which included 13 tertiary hospitals and 15 secondary hospitals. We used the standard methods developed by the World Health Organization and Health Action International to compare the differences in drug price, availability and affordability between secondary hospitals and tertiary hospitals.Results: Overall, the availability of medicine was higher in tertiary hospitals. The average availability of originator brand (OBs) was 13.70% (tertiary hospitals) VS 6.67% (secondary hospitals), and lowest-priced generic (LPGs) was 62.83% (tertiary hospitals) VS 42.92% (secondary hospitals). The MPR value of most sampled medicines in secondary hospitals were less than 1. In contrast, the MPR of Cytarabine (17.15), Oxaliplatin (12.73) were significantly higher than the international reference price. The top three OBs’ total expenses for 30-days treatment were Irinotecan, Oxaliplatin, Bicalutamide. Further, their affordability was relative low, as the costs for one course using these medicines were much higher than 20% of the minimum family monthly income.Conclusion: Though the “Zero Mark-Up” and “Centralized procurement policy of anti-tumor drugs” policies have been implemented in China, the availability issue yet to be addressed. High price and low affordability were the major barriers to the access of essential anticancer medicines. Measures should be taken to provide sufficient, available and affordable medicines to patients in need.

Assessing the prices and affordability of oncology medicines for three common cancers within the private sector of South Africa

Background Prices of cancer medicines are a major contributor to the cost of treatment for cancer patients and the comparison of these cost needs to be assessed. Objectives To assess the prices of cancer medicines for the three most common cancers ((breast, prostate and colorectal) in the private healthcare sector of South Africa. Methods The methodology was adapted from the World Health Organization (WHO)/ Health Action International (HAI) methodology for measuring medicine prices. The Single Exit Price (SEP) variations between product types of the same medicine between the highest- and lowest-priced product and between Originator Brand (OB) and its Lowest Priced Generic (LPG) of the same medicine brand was compared, as of March 2020. The affordability of those medicines for cancer usage based on treatment affordability in relation to the daily wage of the unskilled Lowest-Paid Government Worker (LPGW) was also determined. Also, a comparison of the proportion of the population below the poverty line (PL) before (Ipre) and after (Ipost) procurement of the cancer medicines was determined. Results SEP Price differences ranged from 25.46 to 97.33% between highest- and lowest-priced products and a price variation of 72.09% more for the OB than the LPG medicine, except for one LPG that was more expensive than the OB. Affordability calculations showed that All OB treatments for all three cancers (breast, prostate and colorectal), except for paclitaxel 300 mg (0.2 days wage) and Fluorouracil (Fluroblastin) 500 mg (0.3 days wage) costs respectively were more than 1 day’s wage, with patients diagnosed with colorectal cancer needing 32.5 days wages in order to afford a standard course of treatment for a month. Conclusion There was a considerable variation in the price of different brands of cancer medicines available in the South African private sector.

What Factors Hindered the Access to Essential Anti-Cancer Medicine in Public Hospitals amongst the Local Population in Hubei Province, China?

BackgroundCancer poses a serious threat to one’s health, which caused significant economic burden on the family and society. Poor availability and affordability resulted in some essential medicines failing to meet the basic health needs of this group of patients. The objective of this study was to evaluate the availability, prices and affordability of 32 anticancer essential medicines in Hubei Province, China.MethodsData on the availability and price related information of 32 essential anticancer medicines in the capital and five other cities of Hubei Province were collected. A total of 28 hospitals were sampled, which included 13 tertiary hospitals and 15 secondary hospitals. We used the standard methods developed by the World Health Organization (WHO) and Health Action International (HAI) to compare the differences in drug price, availability and affordability between secondary hospitals and tertiary hospitals. ResultsOverall, the availability of medicine was higher in tertiary hospitals. The average availability of originator brand (OBs) was 13.70% (tertiary hospitals) VS 6.67% (secondary hospitals), and lowest-priced generic (LPGs) was 62.83% (tertiary hospitals) VS 42.92% (secondary hospitals). The MPR value of most sampled medicines in secondary hospitals were less than 1. In contrast, the MPR of Cytarabine (17.15), Oxaliplatin (12.73) were significantly higher than the international reference price. The top three OBs’ total expenses for 30-day treatment were Irinotecan, Oxaliplatin, Bicalutamide. Further, their affordability was relative low, as the costs for one course using these medicines were much higher than 20% of the minimum family monthly income.ConclusionThough the “Zero Mark-Up” and “Two Vote” Policies have been implemented in China, the availability issue yet to be addressed. High price and low affordability were the major barriers to the access of essential anticancer medicines. Measures should be taken to provide sufficient, available and affordable medicines to patients in need.

BIOWAIVER STUDY OF IMMEDIATE RELEASE GLIMEPIRIDE TABLETS

Objective: Demonstrating therapeutic equivalency regarding the efficacy and safety among originator products and generics is a key step in permitting the marketing of generic products. The study aimed to evaluate the bioequivalence of five different generic brands of Glimepiride tablets under biowaiver conditions. Methods: The quality of the tablet products, including uniformity of weight, friability, and disintegration test, was assessed using the United State Pharmacopeia (USP) general monograph for the tablet dosage form. The content of glimepiride in the tablets was measured using UV spectrophotometer at the wavelength 229 nm. The release of Glimepiride from the tested and originator tablet products was evaluated using the dissolution profiles conducted in HCI buffer pH 1.2, and phosphate buffer pH 6.4 and 7.8 by USP dissolution apparatus II. The bioequivalence of test products was assessed using the similarity and difference factors. Results:The tested products complied to USP requirements for quality standards; all the products show rapid disintegration, D1 show higher time (Three minutes) while D3 show lower time (28 seconds). The content of test products was (104.68, 93.75, 97.21, 97.03, and 102.10) for D1, D2, D3, D4, and D5 , respectively, compare to 103.70 for OB. Dissolution profiles revealed that the highest similarity to the originator was showed in pH 6.4; f2 ranged (74.5-68.4) for all the tested products and low similarity in pH 7.8; f2 ranged (45.2-64.7). Conclusion: The study showed that the generic products has noticeable similarity with the originator brand and it can be interchangeable.

Global Pharmaceuticals and East Africa

This chapter traces the shift in the pharmaceutical markets in Kenya, Tanzania, and Uganda from markets dominated by originator (brand-name) drugs produced by western companies to markets dominated by generic drugs produced in the global South, most prominently, in India. The rise of Indian exports was not simply a consequence of conditions in India, as it is often suggested. In East Africa, it was also a consequence of market liberalization imposed through Structural Adjustment Programs (SAPs) on the three countries in the 1980s and 1990s. Specifically, the removal of foreign exchange restrictions—combined with inadequate regulation of the pharmaceutical market—allowed an unmonitored entry of drugs into the private market. The chapter then describes the ongoing efforts by multinational pharmaceutical companies to slow down that shift—especially by strengthening intellectual property rights. It also examines why reports on the prevalence of Chinese drugs in East Africa are greatly exaggerated.

ANALYSIS OF SOME FACTORS AFFECTING ACCESS TO ESSENTIAL MEDICINES IN THE CITY AND SOME DISTRICTS OF THUA THIEN HUE PROVINCE

Background: Essential medicines play an important role in the primary health care program. At least one third of the world’s population has no regular access to these medicines. The availibility and price are two of factors affecting access to essential medicines. Objective: To analyse the availability and the price of essential medicines in the city and some districts of Thua Thien Hue Province. Methods: Using the WHO/ HAI methodology. Results: The originator brand drugs were less available as compared to the lowest price generics. Median availability of originator brand drugs and lowest price generics were 0.0% and 40.0% in public sector. Similarily, these values were respectively 20.0% and 53.3% in private sector, 0.0% and 50.0% in other sector. The median MPRs of innovator drugs was 9.26 and 14.00 for private and other sector respectively while that of generic equivalent versions was 0.68 for public sector, 1.88 for private sector and 1.54 for other sector. Conclusion: The avalibility of originator products was lower than that of lowest price generics. Although the median price of originator brand drugs was much higher than the international reference prices, generic price was almost reasonable. The availibilty as well as the median MPRs figure for the private sector was higher than that for the public sector and other sector. Key words: Medicine prices, availability, essential medicines, WHO/HAI methodology, median price ratio (MPR)

Price, availability and affordability of medicines

Background: Medicines play an important role in healthcare, but prices can be a barrier to patient care. Few studies have looked at the prices of essential medicines in low- and middle-income countries in terms of patient affordability.Aim: To determine the prices, availability and affordability of medicines along the supply chain in Swaziland.Setting: Private- and public-sector facilities in Manzini, Swaziland.Methods: The standardised methodology designed by the World Health Organization and Health Action International was used to survey 16 chronic disease medicines. Data were collected in one administrative area in 10 private retail pharmacies and 10 public health facilities. Originator brand (OB) and lowest-priced generic equivalent (LPG) medicines were monitored and these prices were then compared with international reference prices (IRPs). Affordability was calculated in terms of the daily wage of the lowest-paid unskilled government worker.Results: Mean availability was 68% in the public sector. Private sector OB medicines were priced 32.4 times higher than IRPs, whilst LPGs were 7.32 times higher. OBs cost473% more than LPGs. The total cumulative mark-ups for individual medicines range from 190.99% – 440.27%. The largest contributor to add-on cost was the retail mark-up (31% – 53%). Standard treatment with originator brands cost more than a day’s wage.Conclusion: Various policy measures such as introducing price capping at all levels of the medicine supply chain, may increase the availability, whilst at the same time reducing the prices of essential medicines for the low income population.

Formulation Development and in vitro Evaluation of Drug Release Kinetics from Sustained Release Aceclofenac Matrix Tablets using Hydroxypropyl Methyl Cellulose

The objective of the present study was to develop a once-daily sustained release matrix tablet of Aceclofenac using hydroxypropyl methyl cellulose (Methocel K 100M CR) as release controlling factor and to evaluate drug release parameters as per various release kinetic models. The tablets were prepared by direct compression method. The powder blends were evaluated for angle of repose, loose bulk density, tapped bulk density, compressibility index, total porosity and drug content etc. The tablets were subjected to thickness, weight variation test, drug content, hardness, friability and in vitro release studies. The in vitro dissolution study was carried out for 24 hours using United States Pharmacopoeia (USP) 22 paddle-type dissolution apparatus in phosphate buffer (pH 7.4). The powder blends showed satisfactory flow properties, compressibility index and drug content etc. All the tablet formulations showed acceptable pharmacotechnical properties and complied with pharmacopoeial specifications. The results of dissolution studies indicated that the formulation F-3 (40% Methocel K100M CR of total weight of tablet) could extend the drug release up to 24 hours and the total release pattern was very close to the theoretical release profile. By comparing the dissolution profiles with the originator brand of Arrestin SR, the formulation F-3 exhibited drug release profile like originator brand. From this study, a decrease in release kinetics of the drug was observed by increasing the polymer concentration. Kinetic modeling of in vitro dissolution profiles revealed the drug release mechanism ranges from diffusion controlled or Fickian transport to anomalous type or non-Fickian transport, which was only dependent on the type and amount of polymer used. The drug release followed both diffusion and erosion mechanism in all cases. The drug release from the formulation (F-3) was satisfactory after 3 months storage in 400C and 75% RH. Besides, this study explored both of the optimum concentration and effect of polymer(s) on Aceclofenac release pattern from the tablet matrix for 24 hour period. The matrix tablet of Aceclofenac using HPMC with molecular weight of K100M controlled the drug release effectively for 24 hours; hence the formulation can be considered as a once daily sustained release tablet of Aceclofenac in order to improve patient compliance. DOI: http://dx.doi.org/10.3329/dujps.v11i1.12485 Dhaka Univ. J. Pharm. Sci. 11(1): 37-43, 2012 (June)