Tag Archives: Pharmacovigilance

ISMPS 2014 – Abstracts

Pharmacology for Africa: An Appraisal

Oliver DW, Brink CB

School of Pharmacy, North-West University, Potchefstroom, South Africa

Pharmacology is the specialised discipline concerned with how medicinal drugs work in biological systems and how they are utilised in therapeutics. It is of interest to the medical, pharmaceutical and allied health professions, and key to rational drug use and regulation. Research and training in pharmacology is vitally facilitated by the academia, co-ordinated by learned societies. The latter have developed slowly in Africa, marked by fewer scientific meetings and scholarship exchange. By 2005 only South Africa and Egypt had been paid members of the International Union of Basic and Clinical Pharmacology (IUPHAR). South Africa planned a bid to host the 17th World Congress of basic and Clinical Pharmacology in Cape Town in 2014, which became a beacon for pharmacologists on the continent to stand together and to establish a sustainable movement of African pharmacologists beyond.

The aim was to establish the ‘Pharmacology for Africa’ (PharfA) initiative to organise and promote Pharmacology on the African continent.

PharfA was founded in 2006, South Africa won the 17th World Congress bid and Africa became an integral partner. Several meetings between African pharmacologists and international stake holders were held to steer the strategy and objectives of PharfA, and several training workshops were held across the continent.

A core leadership slowly emerged and formulated the plans and key outcomes of PharfA. By 2012, PharfA was so well supported, that a successful All African Congress of Pharmacology was hosted in Accra, Ghana, a milestone for African pharmacologists. Kenya, Uganda and West Africa came on board, with more development in East Africa to follow soon. Several international funders have supported PharfA. The World Congress, also hosting several symposia on areas of topical interest to Africa, supported delegates from Africa to participate.

Today, only 8 years later, PharfA, has received continental and international recognition as the vehicle to foster Pharmacology on the African continent. PharfA has led several remarkable activities and achieved outstanding milestones for organised Pharmacology on the continent.

Medicine Profile: A Quality Approach Ensuring Patient Safety

Oliver DW

School of Pharmacy, Division of Pharmacology, North-West University, Pharmacen, Potchefstroom, South Africa douglas.oliver@nwu.ac.za

Since prehistoric times humankind has been taking substances derived from natural sources, i.e. for soil, animals and plants, in an attempt to treat disorders of the human body and mind. Eating soil-like or earthy substances (geophagy) such as chalk and clay have been done for hundreds of thousands of years. Man may have copied animals, observing how some clays, when ingested, may have had healing qualities. Some clays are known to be useful for treating wounds. With time the use of these remedies has evolved as intellectual knowledge increased amongst communities. Individuals also started to examine these practices and remedies more closely leading to specific observations that the safety and effectiveness of the treatments are indeed variable and dependent on a variety of factors. These observations served as stimuli for the first attempts of these early peoples to aim to improve the “quality” of their “medicinal products”.

The aim of this presentation is address the safety of the medicinal product from the prospective of the quality characteristics of the product and to provide understanding of the factors to be considered when evaluating the impact on its safety at the patient level.

Modern medicine has developed exponentially in recent decades. Computational technologies, manufacturing advances and have created immense complexities within drug discovery and medicine development but also assisted in quality by design, good manufacturing practices and risk management sciences to ensure reproducibility and consistency of medicinal products. Medicine regulators around the world have increasing developed scientific approaches to ensure the quality of medicines.

Critical elements to be considered include specific country specific country or regional requirements. In spite of the commendable efforts to harmonize the requirements across different regions such as the International Conference of Harmonization (ICH) and the Common Technical Document (CTD) format and event on the African continent there are unique country specifics such as supply chain and target populations, pharmacoepidemiology to be consider. Understanding and ensuring that the quality characteristics of the medicinal product, in relationship to the particular route of administration (oral versus intravenous drug product) and pharmaceutical dosage form (solution, capsule, tablet, aerosol) is maintained through the life cycle of the product is of critical importance. Factors affecting the chemical and physical stability not only of the active pharmaceutical ingredient (API) but also the dosage form need to be fully understood within the context of the clinical use (setting), type of therapy (life-saving versus quality of life) and evidently the safety of the patient.

In conclusion, in depth knowledge of the critical quality attributes of the pharmacological agent is essential in profiling the target medicinal product to ensure safety at the patient level.

Safe use of medicines in patient with renal disease

J Kabahizi, MD

King Faisal Hospital and Rwanda Military Hospital, Kigali, Rwanda

Medication use accounts for 2% of hospital admissions for acute renal failure and up to 15% of admissions into intensive care. Up to 16% of patients with baseline normal renal function who experience renal failure within the hospital setting have medication-induced renal failure.

The metabolism and excretion of many drugs and their pharmacologically active metabolites depend on normal renal function. Accumulation and toxicity can develop rapidly if dosages are not adjusted in patients with impaired renal function.

Dosages of drugs cleared renally should be adjusted based on the patient’s renal function (calculated as creatinine clearance or glomerular filtration rate); initial dosages should be determined using published guidelines and adjusted based on patient response; serum drug concentrations should be used to monitor effectiveness and toxicity when appropriate.

Understanding the mechanisms involved, and recognizing the clinical presentations of renal dysfunction arising from use of commonly prescribed medications, are important if injury is to be detected early and prevented.

Using High Risk Drugs in Maternity: 12 Principles To Remember

Washington Clark Hill, MD, FACOG
HRH for Health Program Rwanda and Maternal-Fetal Medicine;
Duke University School of Medicine, Durham NC, USA.

1. Use during pregnancy only well known and well-tried drugs and NOT the newest.
2. The benefit may OUTWEIGH the risk.
3. The critical period of organ development extends from day 31 to day 71 after the first day of the last menstrual period.
4. Most drugs are SAFE during pregnancy. Categories to be discussed: drugs safe at the recommended dose; drugs usually safe in the absence of allergies; drugs usually not harmful; drugs that may be harmful but used when benefit outweighs risk; drugs unsafe – do not ever use.
5. Don’t put women of reproductive age with chronic conditions such as high blood pressure on drugs that could hurt a fetus WITHOUT contraception.
6. Infants of epileptic women taking anticonvulsants have double the rate of malformations of unexposed infants.
7. Heparin or enoxaparin are drugs of choice for anticoagulation during pregnancy – NOT warfarin.
8. Most antibiotics are SAFE during pregnancy except tetracycline, quinolones and chloramphenicol – BUT check first for history of allergy.
9. Exposure to HIGH-DOSE ionizing irradiation during gestation causes microcephaly and mental retardation; however, diagnostic exposures of less than 5 cGy are considered NOT to pose increased teratogenic risks.
10. Only a small amount of prednisone crosses the placenta, so it is the preferred corticosteroid for most medical illnesses. In contrast, dexamethasone readily crosses the placenta and is preferred for acceleration of fetal lung maturity.
11. Most drugs are SAFE during lactation because sub-therapeutic amounts appear in breast milk, about 1% to 2% of the maternal dose.
12. Remember you have TWO patients: a MOTHER and a FETUS so use drugs during pregnancy with knowledge!

Traditional Medicine and Patient Safety

Padua Fiona

King Faisal Hospital, Rwanda

Background: Over 4 billion people use herbal remedies as their source of primary care. Herb-drug interactions pose a major threat to our patients’ safety. Estimates of use of traditional medicines, herbal and other supplements range from 50% in Italy and in the UK, and up to 80% in Rwanda and other regions in Sub-Saharan Africa.

Challenges: Reasons include cultural beliefs in the effectiveness of traditional medicines, lack of capacity in low resource health care systems to cater for the medical needs of their population, especially in the absence of comprehensive health insurance systems, and in both low resource and more developed systems lack of confidence in modern evidence-based medicine. However physicians do not routinely ask patients if they are taking any herbal medications or supplements and patients may not freely disclose the ingestion of “natural” supplements even if asked to do so.

Concerns: Key risks from use of traditional medicines are five-fold: referral for serious medical problems may be delayed. This may reinforce concern about conventional medicine because, at a more advanced stage, the likelihood of responding to conventional medicine is much reduced. Traditional medicines may directly cause a range of serious adverse effects, including liver failure and acute kidney injury. Herbal remedies can affect absorption, metabolism, distribution, and excretion mechanisms when administered with prescription drugs since drug-metabolizing enzymes may be induced or inhibited by bioactive agents in herbal products. Patients switching to a traditional remedy and stopping other treatment are at high risk of losing control of serious diseases such as cancer. Traditional medicines – as for conventional medicines – may be sub-standard, counterfeit and contaminated. For example, in a 2006 government study in China, 11% of traditional products were contaminated e.g. with mercury, prednisolone or NSAIDs, and there have been reports in Sub-Saharan Africa of addition of cytotoxic anti-cancer agents to herbal remedies.

Drug:herb interactions: Concomitant use of herbal remedies may cause important pharmacokinetic and pharmacodynamics interactions with prescribed and OTC medications. A pre-operative study of 478 patients from three hospitals in Florence established that 50% of patients used herbal remedies and 23% were exposed to a potentially harmful herb-drug interaction. Clinical peri-operative risks associated with herb-drug interactions included cardiac instability, electrolyte imbalance, prolonged bleeding and excessive sedation.

Conclusions: Despite their widespread use, relatively little is know about bioactive components of traditional treatments or their specific risks and benefits. There is an urgent need to raise awareness among health professionals and the public of the risks of traditional remedies, to study potentially beneficial as well as harmful components of these treatments, and thus to be able to provide strong evidence-based regulation, including quality control of safe and effective traditional remedies.

Ekor, M. (2014). The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety. Front. Pharmacol. 4:177. Doi: 10.3389/fphar.2013.00177

Skalli, S., Zaid, A. and Soulaymani R. (2007). Drug interactions with herbal medicines. Ther. Drug Monit. 29, 679-686. Doi: 10.1097/FTD.0b013e31815c17f6″


Yang-tonifying traditional Chinese herbs and their potential phytoandrogenic activity

Munyangaju Jose Edouard, MIAO Lin, FAN Guan-Wei, Barnabas Bessem Orang Ojong, ZHEN Hu, ZHANG Ju, GAO Xiu-Mei, ZHU Yan

Tianjin State Key Laboratory of Modern Chinese Medicine and Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China

The concept of phytoandrogens, plants that contain androgens or those that stimulate androgenic activity in men, is relatively new. In traditional Chinese medicine a number of phytoandrogens are classified in herbs restoratives for reinforcing yang, and they find their applications in the treatment of the kidney yang deficiency diseases. In this review we list the phytoandrogens used in traditional Chinese medicine and present their proven applications in the treatment of kidney yang deficiency diseases such as sexual disorders, cancer, and obesity and associated metabolic syndromes. As a background, we also discuss the mechanism of action of androgens, their synthesis and metabolism, the interrelations of androgens and estrogens as well as the state of art methods to detect and analyze these hormonal activities in medicinal plants

Chinese Journal of Natural Medicines 2014, 12 (5): 0001-0014


Problems of irrational drug use

Kirimuhuzya Claude

Kampala International University-Western Campus, Department of Pharmacology and Toxicology, Faculty of Biomedical Sciences, P.O.Box 71, Bushenyi, Uganda.

Introduction: Rational drug use has been defined as “use of drugs in which patients receive medicines appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community”. Unfortunately, prescribing patterns do not always conform to presented criteria and can be classified as inappropriate or irrational. Common patterns of irrational prescribing may manifest in various forms which may be a result shortcoming related to the patient, the prescriber, the dispenser/pharmacist, the health facility, the community or the health care system itself. This presentation will bring out factors underlying irrational drug use (including the role played by beliefs in traditional African medicine), describe two pilot studies on rational drug use carried out in Uganda, and finally bring out a brief description of studies that can be conducted to detect irrational drug use.

Methods: The methods used included widespread literature review, direct observations and use of questionnaire-guided interviews. Human participant involvement was after obtaining informed consent..

Results: Literature search revealed that irrational drug use may manifest in the use of: (a) drugs when no drug therapy is indicated (b) the wrong drug for a specific condition requiring no drug therapy (c) drugs with doubtful or unproven efficacy (d) drugs of uncertain safety status e) correct drugs with incorrect administration, dosages, and duration (f) unnecessarily expensive drugs or g) dispensing prescription drugs when no prescription has been presented and (h) irrational prescribing. In the study conducted it was revealed that most of the practices fell short of the recommended WHO standards. The second study demonstrated a high prevalence of self-medication in the study area, with costly medical care, poverty, and the multitude pharmaceutical outlets being the most determinants of self-medication.

Conclusions: Ensuring that the correct drug is given to the correct patient is a high priority for all health professionals. Means exist to measure drug use, to intervene to change drug use, and to evaluate these interventions. Health planners and prescribers need to use these tools to improve the quality of care provided to their patients.

  1. http://www.who.ch/programmes/dap/icium/posters/1A2_txt.html
  2. 2. WHO (2008). Problems of Irrational Drug Use (http://archives.who.int/PRDUC2004/RDUCD/Session_Guides/problems_of_irrational_drug_use
  3. 3. WHO, (2004). The World Medicines Situation. Last updated: September 25, 2012. Available at: http://apps.who.int/medicinedocs/en/d/Js6160e/ v.

E-mail: claude.kirimuhuzya@kiu.ac.ug or kirimuhuzya@gmail.com

Cultural competency among prescribers: is it achievable with the current medical curricula and mode of training?

Kirimuhuzya Claude

Kampala International University-Western Campus, Department of Pharmacology and Toxicology, Faculty of Biomedical Sciences, P.O.Box 71, Bushenyi, Uganda.

Introduction: Cultural Competency involves the integration and transformation of knowledge about individuals and groups of people into specific standards, policies, practices and attitudes, to increase the quality of health care; thereby producing better health outcomes. If properly inculcated into the health workforce, it leads to improved provision of health care especially in societies like ours in Africa where there is a great deal of cultural diversity. This study was undertaken to: (1) analyse the current competency – based curriculum in Ugandan medical schools to identify areas where aspects of cultural competences are catered for; (2) carry out a literature search for information related to implementation of curricula used to produce culturally competent health providers.

Methods: The study began with the review of the Competence-based (CB) Curriculum currently being used by the Medical schools in the Ugandan medical schools. The competence base curriculum was reviewed with consent from the authors. This was followed by review of literature about cultural competency among the healthcare providers.

Results: Analysis of the CB curriculum revealed that only one out of the nine major competency areas and only three out of the 59 sub-competences directly addresses cultural competency. The review also made it clear that there were no major strategies in place that would make the health workers training using the curriculum, culturally competent. Literature review provided information on benefits of having a culturally competent health work force and on what makes a culturally competent health worker. The review also provides a prescription for the approaches that need be used during training of a culturally competent health work force. The review also identifies the skills that need to be possessed by a culturally competent health care provider.

Conclusion: A cultural competent health workforce is vital for our culturally diverse society. There is need to review the implementation of the current medical curriculum to enable it provide strategies for creation of such a workforce.”

1.Kripalani S, Bussey-Jones J, Katz MG, and Genao I (2006). A Prescription for Cultural Competence in Medical Education J Gen Intern Med. Oct 2006; 21(10): 1116–1120.

2. Quyen Ngo-Metzger, Joseph Telfair, Dara H. Sorkin, Beverly Weidmer, Weech-Maldonado R, Hurtado M, and Hays R D (2006).Cultural Competency And Quality Of Care: Obtaining The Patient’s Perspective. Available at: http://www.cmwf.org
3. Kamarudin G, Penm J, Chaar B, Moles R (2013). Educational interventions to improve prescribing competency: a systematic review . BMJ Open; 3: 8″

E-mail: claude.kirimuhuzya@kiu.ac.ug or kirimuhuzya@gmail.com

Pharmacovigilance at a national referral hospital: local system and initial patterns of suspected adverse drug reactions.

Rutaganda E1 ,2, Dusabejambo V1,2, Nyiligira J1,3, Singer DRJ1,3,4

1Centre Hospitalier Universitaire de Kigali (CHUK), Kigali, Rwanda; 2Departments of Internal Medicine and 3Pharmacy, University of Rwanda; 4Yale School of Medicine, Connecticut, NH, USA; 5 Human Resources for Health Program, Rwanda.

Background: Pharmacovigilance is vital for patient safety, as adverse drug reactions (ADR) are common and preventable: however internationally ADRs are under-reported. Rwanda has developed ADR reporting systems and tools through affiliation to the WHO Pharmacovigilance Programme and the WHO Uppsala Monitoring Centre.

Aim: We aimed to increase awareness of ADRs at CHUK, to encourage their reporting, and to assess patterns of ADRs among in-patients at the national referral hospital CHUK.

Methods: We used WHO-compliant systems and tools for ADR reporting developed by the Rwanda Ministry of Health (RMoH). An ADR team was formed, consisting of a senior resident, chief pharmacist, and local and external senior clinical staff. Weekly causality reviews were held using WHO criteria. Updates about the importance of pharmacovigilance were provided to doctors, nurses, pharmacists and students at standard seminars, during ward rounds, and during visits to out-patient departments. An ADR was defined as a suspected harmful response to one or more medicines – whether prescribed, OTC or traditional, and whether known or new. The standard RMoH reporting form was used. Data are means + SEM.

Results: Data are presented for a 4 week pilot phase, aimed at enhancing and assessing policies and practice for embedding ADR reporting within standard CHUK patient safety systems. 28 reports were received concerning 27 patients (age 42+3(SE) years, range 21-86; 11 males, age 44+4 years, height 1.73+0.02m, weight 55.0+3.3kg ; 17 female, age 42+4 years; height 1.63+0.02m, weight 54.7+3.4kg; Emergency Room 10, Internal Medicine 17, Renal 1; Kigali 16, other areas 12). Co-morbidity included: HIV 10 (TB with 5, including one with candidiasis and PCP); renal disease 3; hypertension 4, diabetes mellitus 4; anaemia 3; CLL 1; none in 5. ADRs were related to traditional medicines (5), NSAIDs (3), antibiotics (8), anti-retrovirals (3), prednisolone (2), and 1 each for enoxaparin, metformin, OCP, pethidine and quinine. One report was for a reaction to blood transfusion. Commonest sites affected were GI (bleeding or vomiting in 8), liver (6), skin (6) and kidney (4). 6 patients had a recurrence of an ADR with a previously used medicine. Most recovered however at the time this report, 1 each had persisting severe liver injury, kidney and neurological abnormalities. One patient had quinine-associated gangrene. There was one death attributed to acute on chronic liver failure. For causality, 12 ADRs were considered due to a single drug, 10 to multiple drugs and 5 to traditional medicines. In 6 cases, drugs were considered to have exacerbated prior disease. In one patient a metabolic drug interaction with fluconazole was implicated.

Conclusions: We were effective in improving ADR reporting by many departments at this major centre, in identifying an important contribution of ADRs to serious morbidity at CHUK, and in identifying several preventable patterns to the ADRs observed. Similar prior ADRs, drug-disease interactions and traditional medicine use, often unrecognized, were common cause of hospital admissions and delayed detection of serious medical conditions.

Patterns of suspected adverse drug reactions among in-patients at King Faisal Referral Hospital, Rwanda

1,2Amendezo E, 1,2Kambutse I, 1,2Maniraguha YV, 1,2Habimana B, 1Padua F, 1Musabeyezu E, 2,3,4Singer DRJ.

1KFH,Kigali, Rwanda; 2Department of Internal Medicine, University of Rwanda; 3Yale School of Medicine, Connecticut, NH, USA; 4Human Resources for Health Program, Rwanda.

Introduction: Pharmacovigilance is very important for patient safety. Adverse drug reactions are common and preventable. Rwanda is affiliated to the WHO international pharmacovigilance program through its Uppsala Monitoring Centre. However adverse drug reactions are not frequently reported in Sub-Saharan Africa.

Aims: Our aims were to encourage adverse drug reaction (ADR) reporting and to assess patterns of adverse drug reactions at King Faisal Hospital, one of the major referral hospitals in Rwanda.

Subjects and methods: We used WHO-compliant systems and tools for ADR reporting developed by the Rwanda Ministry of Health (RMoH) to assess in-patients at King Faisal Hospital. Our ADR team comprised medical doctors, a hospital pharmacist and an external expert in clinical pharmacology. Weekly causality reviews were done using World Health Organization (WHO) criteria. Updates about the importance of pharmacovigilance were provided to doctors, nurses, pharmacists and students at standard seminars and during ward rounds. An ADR was defined as a suspected harmful response to one or more medicines – whether prescribed, OTC or traditional, and whether a known or a new ADR. The standard RMoH reporting form was used to document the adverse drug reactions”.

Results This report concerns ADRs observed over a four weeks period in October 2014. There were reports of ADRs concerning 9 in-patients (age range 25-62 years, median 43.5 years; 4 females) from three departments: Internal Medicine, Surgery and ICU.

An ADR to a single drug was seen in five patients: chlorpromazine causing hypotension, colchicine causing vomiting, cloxacillin causing bronchospasm, amphotericin B causing severe hypomagnesemia and hypokalemia and indapamide causing severe hypokalemia. These ADRs were managed by stopping the drugs, providing symptomatic treatment and replacing them where necessary.

Drug-illness interactions were observed in three patients: 57M with proximal DVT related to malignancy (metastatic colon cancer) and HIV/AIDS who was taking warfarin 8 months, presented with a lower GI bleed; a 51M with dilated cardiomyopathy and type 2 cardio-renal syndrome, on furosemide, hydrochlorothiazide, carvedilol, losartan and spironolactone, presented with acute gout arthritis, hyperkalemia, and severe acute on chronic kidney injury; 54F with 2 week history of high dose NSAID (diclofenac 100mg tid) postoperatively, who was admitted with renal failure (normal sized kidneys). She was thought to have an underlying autoimmune process affecting her kidneys since she tested positive for anti nuclear antibodies (ANA). It was thought that the NSAIDs contributed to her renal failure. She is currently under renal replacement therapy and undergoing further tests.

Drug-drug interactions were suspected in 3 patients: 57M – fluconazole interacting with newly initiated HAART (atazanavir/ritonavir/abacavir) to cause acute liver failure; 51M – furosemide and hydrochlorothiazide to cause hyperuricemia; elevation of liver transaminases in a 41F on fluconazole and anti-TB therapy (rifampicin, isoniazid, pyrazinamide, ethambutol).

Conclusions: We were able to raise awareness of ADR reporting among inpatients at King Faisal Hospital. Key patterns for suspected ADRs included drug-drug Interactions and drug-illness synergistic adverse effects. In future we aim to assess impact of ADRs on patient morbidity, length of hospital stay, and associated costs, and how increased focus on ADR reporting may reduce preventable morbidity and costs.

  1. WHO – Minimum Requirements for a functional Pharmacovigilance system. 2010
  2. Progress report on the implementation of pharmacovigilance and medicine information system in Rwanda 2011;28-29
  3. The use of the WHO-UMC system for standardized case causality assessment. World Health Organization (WHO) — Uppsala Monitoring Centre. http://www.who umc.org/Graphics/24734.pdf


Pharmacogivilance at a national referral hospital: local system and initial patterns of suspected adverse drug reactions.

1Mugabo F, 1Rutambuka N, 1Walker T, 2,3Singer DRJ

1Centre Hospitalier Universitaire de Butare (CHUB), Huye South, Rwanda; 2Yale School of Medicine, Connecticut, NH, USA and 3Human Resources for Health Program, Rwanda.

Background: Pharmacovigilance is very important for patient safety. Adverse drug reactions are common and preventable. Rwanda is affiliated to the WHO international pharmacovigilance programme through its Uppsala Monitoring Centre.

Aim: We aimed to encourage adverse drug reaction (ADR) reporting and to assess initial patterns of adverse drug reactions.

Setting: In-patients and out-patients at the national referral hospital CHUB.

Methods: We used WHO-compliant systems and tools for ADR reporting developed by the Rwanda Ministry of Health (RMoH). An ADR team was formed of a senior resident, chief pharmacist, and local and external clinical senior staff. Weekly causality reviews were planned using WHO criteria. Updates and about the importance of pharmacovigilance were provided to doctors, nurses, pharmacists and students at standard seminars, during ward rounds, and during visits to out-patient departments. An ADR was defined as a suspected harmful response to one or more medicines – whether prescribed, OTC or traditional, and whether known or new. The standard RMoH reporting form was used.

Results: Data are presented for the initial week of a 4 week pilot phase aimed at enhancing and assessing policies and practice for embedding ADR reporting within standard CHUB patient safety systems. 9 reports were received concerning 8 patients (age range 10-58 years, median 51 years; 5 female) from a wide range of departments: Internal Medicine, the HIV Clinic, ICU, Surgery and Paediatrics. 2 concerned medication errors (ciprofloxocin prescribed – but not administered instead intended co-trimoxazole; cloxacillin prescribed as twice the recommended dose). 2 were related to intake of traditional medicines in both cases severe vomiting precipitating hospital admission: in a girl of 10 who was also found to have severe anaemia, and in a 31 year old women who also developed worsening post-partum oedema and was found to have severe chronic kidney disease (admission creatinine 5mg/dL (425umol/L)). Other ADRs were cloxacillin-induced Stevens Johnson Syndrome (14F); severe dyskinaesia from chronic haloperidol use for treating psychosis (52M); lip swelling and pruritis after 1st dose of nifedipine for hypertension (51M); recurrent hypoglycaemia on metformin and glibenclamide (58F); and generalized rash and pruritis on first dose carvedilol and losartan (51M), resolving during continued treatment with the drugs.

Conclusions: We were effective in improving ADR reporting by many departments at this major centre and in identifying an important contribution of ADRs to serious morbidity at CHUB, including unrecognized use of traditional medicine as a cause of hospital admissions and delayed detection of serious medical conditions.

Mismatches in medicines reconciliation in acute medical in-patients at a tertiary referral hospital


Department of Pharmacy, Centre Hospitalier Universitaire de Kigali (CHUK), Kigali, Rwanda; Departments of Internal Medicine and Pharmacy, University of Rwanda; Yale School of Medicine, Connecticut, NH, USA; Human Resources for Health Program, Rwanda.
Background: There is major interest (1-3) in effective medicines reconciliation to reduce the incidence and severity of Adverse Drug Reactions (ADRs). We assessed challenges to medicines reconciliation in the Internal Medicine Department and investigated the relationship between coded information about medications and allergy on admission compared to direct questioning of the patients or carers about medications on admission and allergy.

Problem statement: Poor documentation is a major source of poor health care quality. In settings where patient charts are not computerized, there may be problems of unclear documentation for all important parts of clinical examination (3). In Western health care settings, medicines reconciliation is a major challenge (1-3).

Aim: To assess the magnitude of mismatching in medicines reconciliation as a way to identify preventable causes of ADRs, including drug-drug interactions, at Kigali University Teaching Hospital

Methods: An audit was conducted for in-patients in the Internal Medicine Department.Data were collected during a continuous 8 day period in late October 2014. We used a standard approach to compare medicines and allergies recorded on admission charts with the medicine history including allergies reported by the patient or their care attendant, as part of quality improvement for patient safety in relation to medicine use at CHUK. Patients were asked to provide indications, names, and doses for their treatment(s) on admission, including over the counter products (OTC) and traditional medicines, and to report any experienced allergy.

Subjects and Results: Results were obtained for 44 patients (19 female; mean age 45.5, range 19-88 years). There were 14 patients concordant for no drug history in the notes or on direct requestioning (5 female; age 51+6 (SE) years). 10 (23%) of these patients had important pre-admission drugs not recorded in the case notes (3 female; age 46+6(SE)years). For the 24 patients recorded as being on no treatment, 10 on review were found to have been on pre-admission treatment – one each for cloxacillin, amoxicillin, clarithromycin, artemether and lumefantrine(co-artem) paracetamol and captopril and 4 on unknown treatments. Case notes also recorded 20 patients (11 female; mean age 41+4 years) as being on pre-admission treatment. One patient (46 year old male) did not recall being on pre-admission treatment with aspirin. Recording of prior treatment was highly significantly poorer in patients recorded in case notes as being on no prior treatment, (P<0.001; Chi2 test).

Conclusions: Medicines reconciliation by a combined pharmacy and internal medicine team identified 1 in 4 patients in whom prior treatments were not identified at the time of admission to hospital. Absence of any prior treatment in the notes appears a strong cue for the medicines history to be revisited. Accurate medicines reconciliation is important both for continuity of important medical care, as well as for recognition of ADRs as a contribution to hospital admission.

  1. Mueller SK, Sponsler KC, Kripalani S, Schnipper JL. Hospital-based medication reconciliation practices: a systematic review. Arch Intern Med. 2012;172:1057–69.
  2. Kwan JL, Lo L, Sampson M, Shojania KG. Medication reconciliation during transitions of care as a patient safety strategy: A systematic review. Annals of Internal Medicine. 2013;158:397–403.
  3. Fernandes O. Medication reconciliation in the hospital: what, why, where, when, who and how? Healthcare Q . 2012;15:42–9.”


Patterns of medical prescriptions at the tertiary level hospital


Department of Pharmacy, Centre Hospitalier Universitaire de Kigali (CHUK), Kigali, Rwanda; Departments of Internal Medicine and Pharmacy, University of Rwanda; Yale School of Medicine, Connecticut, NH, USA; Human Resources for Health Program, Rwanda.

Background: A good medical prescription is a well-filled one in order to minimize dispensing errors and other medication errors leading to adverse drug effects (1, 2). However prescription notes received at hospital pharmacy dispensing desks are commonly observed to be incomplete or unclear. This may impact on the patient in many ways, including toxicity from dispensing the wrong medication and preventable increased severity of disease due to delay of treatment (1).

Aim: To assess current prescription completion technique at the Referral Hospital CHUK to identify areas for improvement in prescribers as an important way to enhance patient safety (3).

Methods: Review was conducted of all parts of prescription orders submitted to the hospital pharmacy to assess how well prescriptions are completed, what is present, missing, incorrect or unclear (3). Data were collected using a standard secure online reporting form.

Results: 174 drug orders were assessed in prescriptions received for 73 patients (32 female, 34 male (gender absent on 7 forms). On 6 forms, more than the expected 4 drugs were requested. Upper case was only used on one form and the Department name was missing on 58 forms. The drug name was unclear in one case, the dose unclear in 2 and absent in 3 cases, the dose incorrect in one case, and dose units unclear in 4 cases. Decimal points were used for 26 drugs, the frequency of dosing was unclear in 3 and absent for 8 drugs, the quantity absent in 15 cases and absent in 1; the duration unclear in 11 cases and the signature unclear in 5 forms and absent in 1 form. Other issues were: brand names used for 28 drugs and abbreviations for 3; date absent for 5 forms; height only provided on 1 form and weight on 4; age was absent on 23 forms, unclear on 6 and no note of units (years or months) on 5 forms. The ID number was absent on 43 forms and only one name provided on 9 forms.

Conclusions: We identified multiple areas for improvement in submitting drug orders to Pharmacy. The most frequent recommendations for improvement as vulnerable areas for patient risk were use of upper case writing, ensuring full patient ID is provided (patient age, ID no. and both names), providing information on height and weight, avoiding abbreviations, use of brand names and use of decimal points. Less frequent issues but important concerns are the need to be clear about drug units, quantity, dose, frequency and date of prescription.

  1. Velo GP, Minuz P. Medication errors: Prescribing faults and prescription errors. British Journal of Clinical Pharmacology. 2009. p. 624–8.
  2. Kadmon G, Bron-Harlev E, Nahum E, Schiller O, Haski G, Shonfeld T. Computerized order entry with limited decision support to prevent prescription errors in a PICU. Pediatrics. 2009;124(3):935–40.
  3. Bignardi GE. Reducing prescription errors. The Lancet. 2010. p. 462.


Plans announced for a Rwanda Society of Pharmacology

Plans were announced for the launch of a Rwanda Society of Pharmacology at the close of the first International Symposium on Medicines and Patient Safety held in Kigali 5-6 November.

The Symposium was attended by over 170 delegates and speakers from 6 countries (Rwanda, South Africa, Moroccoo, South Africa, UK and USA). who participated in an International Symposium on Medicines and Patient Safety was held in Kigali, Rwanda at the College of Medicine and Health Sciences (CMHS) on Wednesday 5th November 2014, followed on 6th November 2014 by an international videoconference on Prescribing Skills with Professor Simon Maxwell and on Pharmacovigilance with Professor Rita Benabdalleh from the WHO co-ordinating centre in Rabat, Morocco. The meeting included talks on medicines and communicable and non-communicable diseases by national and international clinical and policy experts from Rwanda, South Africa, USA and the UK.

The Symposium was held in partnership with Pharmacology for Africa, a consortium of 18 Sub-Saharan countries supported by the International Union of Pharmacology, and led by Professor Douglas Oliver and Professor Christiaan Brink, from South Africa, both of whom spoke at the meeting. The 3 major themes of the symposium were: educating health professionals in safe and effective use of medicines; regulating drugs, including pharmacovigilance and quality of medicines, reducing harm from high risk medicines and in patients with high risk conditions.

Outcomes of the Symposium included plans to launch the first Rwandan Pharmacology Society, publication of selected reviews and commentaries in the international journal Health Policy and Technology, and plans for a Second International Symposium on Medicines and Patient Safety in June 2015, themes to include Improving Prescribing Skills and Rational Guidelines for Antibiotics.

Speakers discussed ways to reduce risk from medicines for treating children and expectant mothers, preventing disorders of the heart and stroke, and for treating cancer and kidney disease. There were also round table discussions not only on prescribed medicines, but also on the risks of over-the-counter and traditional medicines.

Co-organizer and Pharmacist Dr Kayumba said: “The Symposium was timely in building on strategy in Rwanda on pharmacovigilance and on developing our undergraduate and postgraduate educational systems for good practice in use of medicines.”

Co-organizer and Physician Dr Musabeyezu added: “The Symposium provided important updates for doctors, pharmacists and nurses from Referrral and District Hospitals from throughout Rwanda on reducing risk of harm from high risk medicines often used for high risk diseases”.

Co-organizer and Clinical Pharmacologist Professor Singer said: “Medicines have powerful effects to help patients. However medicines also have the potential to cause powerful harmful effects. Education on how to ensure safe and effective use of medicines is therefore vitally important for patients and health services.”

Pharmacology of Africa President Professor Douglas Oliver said: “Partnership with Pharmacology for Africa brings important opportunities to improve patient health and safety through engaging with a wide range of international experts in education, training, clinical practice and research aimed at best practice in use of medicines.”

The symposium was supported by the World Health Organisation, Pharmacology for Africa, the International Union of Basic and Clinical Pharmacology, Partners in Health, the Rwanda Social Security Board, the University of Rwanda College of Medicine and Health Sciences, and by unrestricted educational grants by GSK and Roche.

Information for Editors

For further information, including to arrange an interview with the organisers email ISMPS2014@gmail.com.

Symposium website

Symposium program

Symposium National and International Advisory Board