Funding and financial sustainability of pharmacovigilance: suggested models for funding pharmacovigilance in resource-limited African countries.

Background: An important factor hindering the growth of pharmacovigilance (PV) in resource-limited settings is the lack of adequate funds to establish a functional National Pharmacovigilance System. Consequently, the crucial function of monitoring and ensuring the availability of safe medicines in these settings cannot be guaranteed considering the peculiarities of diseases and medicines used. Objectives: The objective of this paper is to provide an overview as to the availability of potential sources of funds, which could be explored to ensure Medicine Safety and to proffer a potential framework likely to ensure sustainable funding of PV in Africa. Methods/processes: The process of developing this framework entailed a review of PV financing in some developed economies, a landscape study of funding of PV in some African countries, an in-depth understanding of the PV system and the organisational structure and nexus between the regulatory agencies and National Pharmacovigilance Centre. Critical points for consideration included the sources of funds, revenue pool, the disbursement of funds, budgeting and expenditure profile and the legal framework. Consultative meetings, webinars and interviews with experts were carried out. Results: The findings showed that most of the PV systems were mainly integrated into the regulatory agencies regarding operational and fiscal governance with few facilities being independent of the regulatory agencies. The main source of funding was from the government with significant donor funding which is ad hoc and non-sustainable. Several potential sources were identified but yet to be exploited. There were no legal provisions for PV financing. A framework likely to ensure sustainable PV financing is suggested to capture all available sources of funding, mine the potential sources providing a sizeable pool of revenue to address its activities and enabling legal framework which will engender autonomy. Furthermore, it will address the nexus between the regulatory agencies and the PV outfits, thus enabling appropriate share of resources and blockage of diversions. Conclusion: In all, addressing the various elements identified in this study and providing the legal provisions which guarantees some degree of autonomy will provide a sustainable mechanism for PV funding in the resource-limited setting of Africa.

Funding models for pharmacovigilance in resource-limited African countries An important factor hindering the growth of pharmacovigilance (PV) in resource-limited settings following their entry into the WHO Programme of International Drug Monitoring is the lack of adequate funds to establish a functional National Pharmacovigilance System. This article provides an overview of various potential sources of funds in these settings and how they can be harnessed to fund PV. We undertook a review of PV financing in developed settings and carried out a landscape study of funding of PV in some African countries, as well as having an in-depth understanding of the PV system and the organisational structure. The nexus between the regulatory agencies and National Pharmacovigilance Centre was noted. We took into account the sources of funds, revenue pool, the disbursement of funds, budgeting and expenditure profile and the legal framework for the different African countries. We also identified the prevalent and potential sources of funds for PV. Consultative meetings, webinars and interviews with experts in PV were carried out as well. We discovered that most of the PV facilities were mainly integrated into the regulatory agencies regarding operational and fiscal governance with few facilities being independent of the regulatory agencies. The main source of funding was from the government with significant donor funding which is ad hoc and non-sustainable. Several potential sources were identified but yet to be exploited. There were no legal provisions for PV financing. We have now proposed funding models that may lead to increased revenue for PV in these countries as well as suggesting that a legal framework be provided to guarantee sustainability and address the nexus between the regulatory agencies and the PV outfits to ensure an appropriate share of resources and blocking diversions.

National strategy for the integration of pharmacovigilance in the Moroccan TB Control Program.

The objective of this work is to demonstrate the interest of integration of pharmacovigilance in Moroccan Tuberculosis Control Program (MTCP). The integration of pharmacovigilance in MTCP was conducted in October 2012with the Global Fund support. We compared the reports notified before and after this integration (period 1: January 2010-October2012; period 2: October 2012-December 2013). The detection of signals was based on the Information Component available inVigiMine. We used the SPSS version 10.0 and Med Calc version 7.3 for data analysis. The average number of spontaneous reports increased from 3.6 to 37.4 cases/month (P< 10-3). The average age was 40.7 ± 17.5 years; the sex ratio was 0.8. Hepatic reactions (32.7%) predominated during the first period, while skin reactions (24.1%) were in the second period (P = 10-4), and40.9% of cases in the first period were serious against 15.8% in second period (P = 0.003). Nine signals were generated (hepaticenzyme increase, cholestasis, jaundice, arthralgia, acne, lower limb edema, pruritus, skin rashes, and vomiting). The integration of pharmacovigilance in Moroccan Tuberculosis Control Program improved the management of ADRs and detected new signals of antituberculosis drugs.

[Epidemiology and risk factors for voluntary intoxication in Mali]. / Épidémiologie et facteurs de risque des intoxications volontaires au Mali.

INTRODUCTION: Voluntary intoxication is a major medical and social problem in developing countries and the most common method of suicide attempt. The purpose of this paper is to describe the main characteristics of voluntary intoxication in Mali and the risk factors associated with the outcome of poisoning. More generally, the aim is to contribute to the reduction of morbidity and mortality associated with self-poisoning. METHODS: We conducted a retrospective descriptive study of the cases of deliberate self-poisoning recorded between 2000 and 2010 in 15 Malian hospitals. RESULTS: 884 cases of self-poisoning (233 men and 651 women) were identified during the period of study, representing 28% of all cases of poisoning reported during this period. The mean age of the victims was 23 ± 8.9 years. The available data indicate that the most common cases were suicide attempts and self-induced abortion using toxic substances (respectively 62.8% and 29% of all cases). The most common methods were drugs (74.5%), especially chloroquine (65%), followed by industrial products (9.1%). The most commonly used industrial products were hydrochloric acid (26.7%), sodium hypochlorite (bleach) (22.2%) and sulphuric acid (15.6%). The findings suggest that poisoning symptoms vary depending on the type of substance, the amount ingested and the delay before treatment. 86 of the 877 cases with known outcome resulted in death. CONCLUSION: The number of cases of poisoning is probably underestimated since many cases remain undiagnosed and unreported.

Juniper tar (cade oil) poisoning in new born after a cutaneous application.

Juniper tar (cade oil) is distilled from the branches and wood of Juniperus oxycedrus. It contains etheric oils, triterpene and phenols, used for many purposes in folk medicine. The authors report a case of a previously healthy new born treated with a topical application of Juniperus oxycedrus for atopic dermatosis The poisoning caused convulsions, collapsus, acute pulmonary oedema, renal failure and hepatotoxicity. The newborn survived after supportive and symptomatic treatment, and discharged in a good condition on the eleventh day of hospitalisation in intensive care unit.

Incidence of adverse drug events and medication errors in intensive care units: a prospective multicenter study.

BACKGROUND: In recent years, medication error has received considerable attention because it causes substantial mortality, morbidity, and additional health care costs. Collecting information in this field depends on the willingness of health professionals to report their errors. Another important point is to identify patients at high risk for an adverse drug event (ADE) to oversee the quality of the entire drug distribution chain, including prescription, drug choice, dispensing, and preparation to the administration of drugs. OBJECTIVE: To assess the prevalence rate of ADEs. To ascertain those related to medication errors to develop prevention strategies. DESIGN: Prospective cohort study. SETTING: Multicenter study, 7 intensive care unit in academic and military hospital of Rabat. PERIOD: Three months. PATIENTS: Adult and pediatric patients in medical/surgical intensive care units. COLLECTION DATA: One coordinator for each participating ward collaborates with a pharmacist investigator from Moroccan pharmacovigilance center in the detection of ADEs. MEASUREMENTS AND MAIN RESULTS: Of the 696 patients studied, the investigators identified 108 incidents (15.5 %) (95% confidence interval, 14.1-16.9). The reviewers concluded that 56 (70%) of 80 ADEs were nonpreventable, which, by definition, are considered as ADRs. Among the 52 medication errors, 28 (53.8%) led to potential ADEs and 24 (46.2%) led to actual preventable ADEs. There were 7.7 medication errors for 1000 patient-days. We noted that the preventable ADEs occurred in the prescribing (71.1%), administration (21.2%), transcription (5.7%), and dispensing stages. Errors of wrong or improper drug use accounted for the majority of potential and actual preventable ADEs (23%), followed by improper dose (21.1%), wrong duration of treatment (19.2%),wrong rate of administration(13.5), errors due to drug omission (9.6%), wrong administration technique (5.8%), wrong dosage form (3.8%), and wrong administration timing (1.9%). CONCLUSIONS: This study argues the need for pharmacovigilance to extend its scope to medication errors to improve the safety of drugs. Our results underlined that medication errors are likely to be more serious than ADRs. Our approach based on the collaboration between the pharmacovigilance center and clinicians can be a powerful tool for incorporating error reporting into the culture of medicine.

[The epidemiological situation of scorpion stings in the Beni Mellal province]. / Situation épidémiologique des envenimations scorpioniques dans la province de Beni Mellal.

The objective of this work is to analyse and interpret data from patients bitten by scorpions in a province of Morocco in order to reduce morbidity and mortality caused by scorpion venom. A study was conducted of 901 cases of poisoning among 6959 cases of scorpion stings recorded between January 2002 and December 2006 from bites recorded in Beni Mellal. The results show that poisoning strongly coincides with the summer period, especially in July and August. All age groups are affected by this disease with an average age of 17.28 +/- 17.91 years. For the time post injection, 35.2% were able to check in under an hour. On the other hand, 70.9% reach a health facility with symptoms (class II) and 29.1% with signs of distress (Class III). Finally, the evolution of patients is mostly positive in 94.7% of cases, and the case fatality rate from scorpion sting poisoning is 3.88%.

Drug interactions with herbal medicines.

The use of herbal medicines (HM) is on the rise among the global population. Although the safety profile of many herbal medicines is promising, accumulated data show evidence of significant interactions with medications, which can place individual patients at great risk. A range of electronic databases have been reviewed for articles published in this field: Medline, Allied and Complementary Medicine Database, HealthSTAR, AMBASE, CINHAL, Cochrane Library, as well as Internet documents and manually searched references in medical journals. In this review, we examined the literature from 1966 to 2006 and focused on the importance of the risk of drug interactions and potential side effects when HM are involved. We discuss these in light of the documented findings. A review of the problematic issues is given and recommendations are made in order to encourage the setting up of clinical trials on HM and herb-drug interactions.

[Botanicus and phytotox: data base of plant toxicology. Interest in emergency toxicology and in phytovigilance]. / Botanicus et phytotox: base de données de toxicologie végétale. intérêt en toxicologie d'urgence et en phytovigilance.

The purposes of this project were to summarize more than 279 standard botanical names and their 2294 vernacular ones (French common names, Arabic common names and Moroccan common names) for the first part of database named "Botanicus". The second part of this data base named "Phytotox", concerns relevant toxic data of 120 plants available in Mediterranean region. The database will be useful for emergency physicians, particularly of Maghreb and French- speaking countries. Botanicus and Phytotox permit to assist them in providing fast and appropriate answers to questions concerning adverse effects associated with plant use.

[Serious gastrointestinal effects of nonsteroidal anti-inflammatory drugs (NSAIDS) in a prospective study in Morocco]. / Effets gastro-intestinaux majeurs des anti-inflammatoires non stéroïdiens (AINS): étude prospective marocaine.

In Morocco, the need for post-marketing surveillance of selective Cox2 inhibitors (coxibs) prompted a study to assess the serious gastrointestinal effects of NSAIDs and to compare gastrointestinal tolerance of conventional NSAIDs and coxibs. A prospective study was conducted from April 2001 through May 2002 among hospital-staff gastroenterologists in the public and private sector as well as emergency surgical units. Over this period, 123 patients were reported to have serious NSAID-related gastrointestinal effects, and 63% of them were admitted for bleeding or perforated ulcers. Endoscopy most often identified the lesion as a gastric ulcer (45%). Emergency rooms reported that aspirin was the most common causal agent and that NSAIDs accounted for 8.7% of bleeding and 9.3% of the perforated ulcers. Our findings indicate that men and youth are most vulnerable to serious gastrointestinal effects from these drugs. Several risk factors from the literature were confirmed in our population: history of gastrointestinal disorders and joint disease, occurrence within less than 1 month of beginning the drug; association of NSAIDs and aspirin, diabetes and hypertension. No conclusion could be drawn about the comparative gastrointestinal tolerance of conventional NSAIDs and coxibs, however, since the latter account for only 3% of the NSAID market.

[Acute intoxication by redoul (Coriaria myrtifolia L.). Three observations]. / Intoxication aiguë par le redoul (Coriaria myrtifolia L.). Trois observations.

INTRODUCTION: Coriaria myrtifolla L. (Redoul) is a shrub of the Mediterranean area. Poisoning with this plant is often accidental, following ingestion of the plant's fruit that are often mistaken for blackberries. OBSERVATIONS: Having eaten Coriaria myrtifolla L. berries, three sisters suffered from acute poisoning. One died. COMMENTS: Toxic effects are characterized by digestive (nausea, vomiting, abdominal pain), neurological (obnubilation, convulsions and their complications), and respiratory disorders (polypnea, respiratory problems, apnea, short and superficial respiration) together with myositis of the pupils. Treatment of this poisoning is purely symptomatic. In the case of convulsions, rapid resuscitation in an intensive care unit in necessary.

[Reactive airways dysfunction syndrome (Brooks syndrome)]. / Syndrome de dysfonctionnement réactif des voies aériennes (syndrome de Brooks).

INTRODUCTION: Although the existence of classical occupational asthma is well known and described after fairly prolonged exposure to moderate levels of air-contaminators, authentic asthma can be provoked by rapid single inhalation of a high dosed corrosive gas: this is Brooks' syndrome. OBSERVATION: A 30 year-old woman, without respiratory past history and no atopy presented with post-toxic asthma following a single accidental inhalation of hydrochloric acid. The diagnosis was established on the 8 criteria of Brooks and the clinical outcome remained stable with, however, excellent response to the inhalation of broncho-dilatators during asthma attacks. COMMENTS: The relationship with the accidental inhalation may have been ignored by the victim. The outcome of this syndrome is good in 50% of cases; in 25% the symptomatology worsens and in the remaining 25% it remains stable.