The implementation of the bioequivalence certification policy in Chile: An analysis of market authorization data.

BACKGROUND: Affordability is a key barrier to access to medicines. Generic medicines policies can address this barrier and promote access. Successful uptake of generic medicines depends, in part, on ensuring that these products are interchangeable with reference products. Typically, bioequivalence certification is established in order to demonstrate such interchangeability. OBJECTIVE: To study the implementation of the bioequivalence certification policy in Chile. METHODS: We used Chilean Market Regulatory Authority data for analysis to study the number of products that obtained bioequivalence certification, the time until bioequivalence certification and associated factors to obtain bioequivalence. RESULTS: As of January 2017, out of 2,336 products with a valid market authorization containing at least one of the 167 APIs that required BE certification, 1,026 products actually have BE certification (1,026/2,336, 43.9% compliance). Where data were available, the time between submission of the market authorization as a bioequivalent product to final authorization by the national medicine regulatory authority for most products varied between 4-6 months. The fraction of all BE products containing a given API out of the total marketed products containing that API varies considerably, e.g. for the API olmesartan there was only a single BE product marketed, the API diclofenac had none. CONCLUSIONS: Although the implementation of Chile's bioequivalence policy increased the number of bioequivalent products, over 50% of generic products requiring bioequivalence that did not obtain this certification. Also for some of the API none or very few BE products are marketed which limits the success of a substitution policy. Further studies are required to identify the apparent lack of incentives to obtain bioequivalence certification. Studies of sales volumes and prices of the products are needed to identify whether generic products without bioequivalence certification either become bioequivalent or eventually exit the market.

Human resources in health: an analysis of costs of training, certification requirements & migration issues in Belize

INTRODUCTION: The terms of reference required, inter alia, an analysis of the dynamics of the formation of health professionals in Belize, including available information on the immigration and emigration of these personnel into Belize and the resultant impact on HRH production, deployment, absorption, retention, performance and motivation. METHODS: To undertake the study, it was initially required to focus on the existing clinical science training institutions locally to obtain completion rates for health care professionals, the costs of training, the systems for certification of these professionals and issues regarding migration as a prime determinant of the existing stock of these health care professionals. Acknowledging that there are multiple categories of health care workers, the study focused mainly on nurses and doctors. The former are trained locally at the University of Belize in Belmopan, where after a four year course of study conservatively costing some $20,000 and sitting a regional examination, a student qualifies to practice as a nurse in Belize. Being a national university in receipt of a government subsidy that forms the single largest component of its budget, UB's student fees are deliberately maintained at below market costs. These costs exclude ancillary costs related to academia, such as boarding and lodging, which are substantially more market determined, and when included, costs are easily doubledthe various school fees. Doctors are not trained at UB, though Government does provide scholarships for locals to study medicine at the University of the West Indies, a regional institution also supported by GOB due to its membership in CARICOM. Globally, the market for health professionals is fluid, unregulated and largely undocumented, and Belize is impacted by its fluidity. Belizeans have a long history of emigrating mainly to the USA and while it is believed that health professionals have been among the migrants, there is a paucity of data in this regard. For these professionals immigrating into Belize though, a CSME Skills Certificate must be sought if the person is from any CSME country and if not, then a work permit must be sought. CONCLUSIONS: Most recent data from the Labour Department indicate that various categories of health professionals from as many as twelve countries spanning four continents are an integral component of Belize's existing health workforce. The reasons for the migration of health professionals continue to be many and varied, and there is an active and targeted recruitment programme in the USA. While the migration of these professionals must be regarded as a loss of much needed and scarce human resources in health, there are some positives. Capacity strengthening canoccur as the local health system can be enhanced by partnerships that contribute in specific areas, for example the DangrigaCancer Centre is owned and operated by a Belizean doctor who practices in the USA and occasionally brings fellow specialists to provide treatment services at minimal costs. Acknowledging though that health workers have an inherent right to migrate, the Government of Belize is advised to adopt the WHO's 2010 Code of Practice on the International Recruitment of Health Personnel. The Code of Practice seeks to regulate the migration of health personnel in a way that mitigates the damage to developing countries such as Belize. Other main recommendations focus on increasing the production of HRH. This can be accomplished via the provision of bursaries to students in these areas. Retention strategies are also required to provide pathways for these health professionals. Also being recommended is technical assistance to the Ministry of Health, the Belize Medical and Dental Council and the Nurses and Midwives Council to strengthen the regulatory framework so that they are all able to better keep abreast in tracking their members. At the present time, should a nurse or a doctor leave public employment, the Ministry of Health is not mandated to inform the respective council. Under a strengthened regulatory framework, this would be mandatory. Also mandatory would be the health professional informing in writing the respective council of any changes to his/her employment status or location of employment. This would greatly assist in tracking private doctors and nurses as they relocate to other areas of the country as well as if they migrate abroad. Finally, given Belize's focus on a primary health care model as the basis of its health care system, some consideration ought to be given to further strengthening of the Community Health Workers. These health volunteers are at the base of the local health system and are the most widely dispersed health worker. Consideration is justified because these unheralded workers are most unlikely to migrate since destination countries are selective in their recruitment efforts and exclusively require credentialed professionals as migrants. (AU)

Advanced-practice pharmacists: practice characteristics and reimbursement of pharmacists certified for collaborative clinical practice in New Mexico and North Carolina.

PURPOSE The results of a survey assessing the practice settings, clinical activities, and reimbursement experiences of pharmacists with advanced-practice designations are reported. METHODS A questionnaire was sent to all certified Pharmacist Clinicians in New Mexico and all Clinical Pharmacist Practitioners in North Carolina (a total of 189 pharmacists at the time of the survey in late 2008) to elicit information on practice settings, billing and reimbursement methods, collaborative drug therapy management (CDTM) protocols, and other issues. RESULTS Of the 189 targeted pharmacists, 64 (34%) responded to the survey. On average, the reported interval from pharmacist licensure to certification as an advanced practitioner was 11 years. The majority of survey participants were practicing in community or institutional settings, most often hospital clinics or physician offices. About two thirds of the respondents indicated that their employer handled the billing of their services using standard evaluation and management codes, with estimated total monthly billings averaging $6500. At the time of the survey, about 80% of the respondents were engaged in a CDTM protocol. The survey results suggest that pharmacists with advanced-practice designations are perceived favorably by patients and physicians and their services are in high demand, but more than one third of respondents indicated a need to justify their advanced-practice positions to administrators. CONCLUSION Pharmacists with advanced-practice designations are providing clinical services in various settings under collaborative practice arrangements that include prescribing privileges. Despite growing patient and physician acceptance, reimbursement challenges continue to be a barrier to wider use of CDTM programs.

Effect of emergency medical technician certification for all prehospital personnel in a Latin American city.

BACKGROUND: In Mexico and most other Latin American countries, many emergency medical services (EMS) systems rely on employees and volunteers with only on-the-job training and without formal Emergency Medical Technician (EMT) certification. This study sought to evaluate the costs and effectiveness of providing EMT certification to all personnel working in an EMS service in a Mexican city. METHODS: At baseline, only 20% of the prehospital personnel (medics) working for the EMS service in Santa Catarina, Nuevo Leon, Mexico had EMT certification. During a 14-month period, all such medics obtained EMT certification. The process and outcome of trauma care were assessed before and after this training. RESULTS: Mortality among persons treated by this EMS service decreased from 1.8% Before to 0.5% after the training. The injury severity, as reflected by the prehospital index (PHI), was different between the two periods. Hence, adjustment for PHI by logistic regression was performed. The PHI- adjusted odds ratio for death in the after period was 0.55 compared with the before period, representing a 45% reduction in risk of death after EMT training. CONCLUSIONS: These data support the promotion of policies that require and enable EMT certification for all prehospital care providers in Mexico and potentially also in other Latin American and other middle-income developing countries.