sudan journal of rational use of...

Sudan Journal of Rational Use of Medicine

March 2013 - Issue No.3

JS Directorate General of Pharmacy

Federal Ministry of Health

Publication team

Editor in chief Habab Khalid El Kheir B. Pharm., M. Pharm., Ph.D.

Editors Prof. Awatif Ahmed Osman B. Sc. N, M.Sc. N., Ph.D.

Mahmoud Mudawi Eltahir B. Pharm., M. Pharm., Ph.D.

Aimun Abdelgaffar Elhassan B. Pharm., M. Pharm., Ph.D.

Alya Faysal AL-Mahdi B. Pharm., M. Pharm., M.Phil, mGPhC

Nuha Mohamed A. Agabna B. Pharm., M. Pharm.

Akifa Ismail Elrufai B. Pharm., Dip. NGOs

Yasir Mirghani Abdalrahman B. Pharm.

Sawsan Eltaher Ahmed B. Pharm.

Graphic Design Mahmoud Gahalla Ahmed

Advisory board Prof. Abdalla O. Elkhawad B. Pharm., M.Sc., Ph.D.

Prof. Kamal Eldin Eltayeb Ibrahim B. Pharm., Ph.D.

Prof. Sami Ahmed Khalid B. Pharm., M. Pharm., Ph.D.

Acknowledgement

The Directorate General of Pharmacy gratefully acknowledges the financial support of the Global Fund to fight against HIV/AIDS, Tuberculosis and Malaria. This work would not have been possible without technical support of World Health Organization.


Contents1

Contents2Editorial

2Where Are We?

3Obituary

4Current Topic

5

• The Multidisciplinary Team Approach to Healthcare

Practice Issues

• Dispensing Prescription Only Medicines (POM) as Over The Counter medicines (OTC)

6Research Articles

• Assessment of the Availability of Tools to Ensure RUM in Khartoum State Public Hospitals.

• Assessment of the Performance of Pharmacy and Therapeutic Committees in Khartoum State Public Hospitals in 2011

• Drug-Drug Interactions among Sudanese Patients with Ischemic Heart Disease

12

14

News and Updates

Guidelines to Good Practices

• Responding to Requests of OTC Over The Counter Medicines. Guide for Junior Pharmacists and Pharmacy Students

16Useful Tips

• Proper Use of Metered-Dose Inhalers

17Questions and Answers

• Multi-disciplinary Approach to achieve RUM

18Educational Materials

• Pharmacy and Therapeutic Committees (PTCs) or Drug and Therapeutic Committees (DTCs)


Dear fellows and readersWelcome to the third issue of SJRUM.

Welcome to the third issue of SJ RUM. In order to maintain health resources and to ensure a good quality

of life for patients under treatment, it is essential to promote the rational use of medicines. This goal cannot be achieved single handed; we need to work hard to provide a level of quality health services and even harder to maintain it. The best approach is to involve all healthcare providers and to work collaboratively.Pharmacy and Therapeutic Committee (PTC)is one of the best examples for multidisciplinary teams, where all health actors are involved in medicines decisions. The involvement of nurses, psychologists, nutritionists and clinical pharmacists in therapeutic decision making is

another good example. We hope that this edition of the journal will provide a good insight into multidisciplinary work in Sudan.We will highly appreciate your comments and contribution swhich will enrich future issues.

Editor-in-chief Dr. Habab K. Elkheir

Editorial 2

Where are we from multidisciplinary team work in Sudan?

Khartoum statePTCs were established relatively late in Khartoum state public hospitals. The 1st one was developed in 2004.The total members of the PTCs in Khartoum State range from 7 to 14 members. The PTCs’ membership was diverse including medical doctors (64.4 %), pharmacists (24.5%), nurses (7.8%), and administrators (3.3%).The chairman of PTCs was the general manager of the hospital and the executive secretary was the senior pharmacist in all PTCs in Khartoum state.

North Kordofan StatePTC was recently established in Elobeid Hospital with five members; three medical staff and two pharmacists.

Drug and Therapeutic Committee (DTC), or Pharmacy and Therapeutic Committee (PTC), is one of the best examples of multi disciplinary team, where all healthcare providers are involved in medicines decision from selection , procurement, protocols and guidelines,up to medicine use at patient’s level. At national level the PTCs are established in two states, namely Khartoum and North Kordofan.


3

Kamal Eldin Ibrahim age 64, passed away at a hospital in Saudi Arabia, surrounded by his family on Thursday 28/3/2013. He was born in Shambat, Khartoum North. His preliminary education started at Shambat Western School, Khartoum North Intermediate School and then Khartoum North High School. He joined the Faculty of Pharmacy at Khartoum University in 1967 and graduated in 1972. After graduation he joined a number of institutions including the pharmaceutical industry, quality control laboratory and finally joined the Faculty of Pharmacy as a research assistant. He went to University of London and qualified as a PhD holder in 1983. He travelled to Florida in the USA and worked as a postdoctoral fellow in the department of neurochemistry at College of medicine,

Gainesville. Following that he was appointed as a lecturer in the department of Pharmaceutical Chemistry in the Faculty of Pharmacy,University of Khartoum. He was a teacher in analytical chemistry during his tenure at U of K and got his professorship in 2000. While working for U of K he went for a one year sabbatical at the Department of Medicinal Chemistry, Pharmacy Section, Faculty of Medicine & Health Sciences, University of Sana’a, Yemen. When he came back to Sudan, he worked as a consultant to a number of pharmaceutical companies in Khartoum. He was appointed the head of the department of Pharmaceutical Chemistry and during the period of 2004 to 2008 he became the Dean of the Faculty of Pharmacy. He was a member of several committees in the Federal Ministry of Health, the State Ministry of Health, the National Medicines and Poisons Board and in many governmental and non-governmental organizations. He supervised a numerous number of master and doctorate students during his work at the University. He also participated in several conferences, seminars, workshops and scientific gatherings in Sudan and abroad.He was very active in student affairs and was pivotal in supporting student’s activities.

Prof. Kamal Eldin as he always wanted to be called by his full first name was loved and respected by all his students and peers alike. He had a great number of followers through his facebook account and always motivated and excited his interactive students by his wit, wisdom and great knowledge in all aspects of life. He loved his family and always talked about his best time when he was at home enjoying the company of his family members especially his grandchildren. His colleagues respected him very much and he was an inspiration and joy to work with. He had a great sense of humor and we all miss him very much.

We all pray for him and ask Allah to rest his soul in heaven and we can only say to his family: you had one of the greatest scientists, family man, a father and a friend for all those who knew him. May God bless him.

Prof.Abdalla Omer Elkhawad.On behave of SJRUM team

Prof. Kamal Elddin Eltayeb Ibrahim

Obituary

The healthcare system has done much to provide effective and efficient care

to patients. Developing Multi-Disciplinary Team (MDT) is an approach to meet the high demands of patients and to best utilize the limited resources. This approach provides better care than an individual plan that has in the past, just involved the doctor. When properly implemented, this MDT approach provides positive measurable outcomes.With a diverse group of healthcare professionals, such as physicians, pharmacists and nurses, they provide a comprehensive assessment through their individual expertise and in consultation with one another. The most important focus of the MDT is the patient. The team provides a comprehensive treatment plan for the patient from initial diagnosis through different processes to achieve therapeutic goals.The members of MDT may change from case to case depending on the diagnosis and the patient’s condition. In general,

the team will include medical professionals from various disciplines, homecare professionals, social services, mental health professionals, nutritionists and health educators. The benefits to the professionals are the opportunities to enhance the professional skills and learning more about the strategies, resources and approaches used by various disciplines. MDT is a built-in consultation component. It also provides the professionals with ongoing support which can be invaluable as they deal with challenging situations and cases. Good examples of MDT are disease boards which may be composed of a medical specialist, radiologist, pathologist, surgeon, psychologist, pharmacist, and nurse. MDT shares the responsibility in deciding the patients’ treatment plan. This approach can lead to better treatment outcomes and reduce treatment costs by reducing hospitalization and improving the patient’s compliance with medical care and follow-up. Professional skills are needed for the best service delivery model, hence an MDT is specifically recommended.

.


Current Topic4

Example of a multidisciplinary team involved in caring for a patient with stroke

Example of a multidisciplinary team involved in caring for a patient with stroke

The Multidisciplinary Team Approach to Healthcare

Case

A 75 years old male was admitted to the emergency department complaining of

a black stool (malena) and blurred vision. After admission the doctor took a full medical history and found out that the patient had a previous deep vein thrombosis and he was on warfarin. He also had been prescribed atenolol for tachyarrhythmia. On further inquiry, the co- patient revealed that the patient was also taking ciprofloxacin and metronidazole which were purchased by his son from a nearby pharmacy 4 days ago as a response to abdominal cramps and diarrhea. Furthermore the co -patient stated that the patient had taken the medicines according to the pharmacist instructions for two days, after which he developed bloody stools. The patient thought this condition was related to his abdominal complains and increased the dose of metronidazole. Within two days, the condition suddenly worsened and the patients had to be admitted to the hospital.

Problems• Pharmacist responding to co-patient

request without referral to a doctor.

• Irrational dispensing of antimicrobials without a prescription.

• Neither medical nor drug history was

Dispensing Prescription Only Medicines (POM) as Over The Counter medicines (OTC)

taken by the pharmacist.

• Poor patient awareness.

InterventionsDoctors• Identified the problem by taking a

comprehensive medical and drug history.

• Succeeded in rectifying the bleeding problem by instating prompt therapeutic measures.

Clinical pharmacist• Identified drug interactions between

metronidazole,ciprofloxacin and warfarin which caused an increase in the level of warfarin in the blood leading to rectal bleeding.

• Provided the patient with useful information about warfarin and its most common drug-drug interactions and drug-food interactions.

The healthcare team• Stopped the antimicrobials and the patient

condition improved.

• Collaborated to monitor the International Normalized Ratio (INR- bleeding time) and adjust the dose of warfarin accordingly.


5Practice Issues

Serious drug interaction explained using the Swiss cheese model (Reason 1990)

Introduction

Several strategies have been proposed for combating the inappropriate use of

medicines particularly antibiotics. Development of formularies, Essential Medicines List (EML), Standard Treatment Guidelines (STGs), and bodies such as the Pharmacy and Therapeutic Committee (PTC), and Medicine Information Centers (MIC) are essential tools to manage and ensure Rational Use of Medicines (RUM).Additionally, education and training of personnel are important to ensure implementation of strategies of RUM and improve benefit at lower cost. Special emphasis is made on antibiotics; because the development of resistance is accelerated when antimicrobials are misused. In developing countries,antibiotics are not only misused, but often underused due to financial constraints1. Hence the objectives of this study were to assess the availability of RUM tools and prescriber awareness in public hospitals in Khartoum State.

Methods The study was a cross-sectional quantitative survey of facilities in the public hospitals in Khartoum State, between June and November 2010. In total, a sample of 15 hospitals were randomly selected for the study. Prescriber awareness was assessed using a pre-validated structured questionnaire. The total number of prescribers in each hospital was obtained from the human resources department. Information about the availability of tools at the individual hospitals was obtained using a direct structured interview with medical managers.

1. El Nao Hospital, Khartoum State.2. Faculty of Pharmacy, University of Medical Sciences and Technology

Results and DiscussionThe study included 15 medical managers and 384 prescribers of which 73 % were junior medical staff, of these 50% had less than two years experience.The responses from the management staff revealed that most of these tools were available and established at the state hospitals specially the specialized ones (tertiary care level). Specifically; the PTC, Infection Control committee and EML were found in 84%, 92% and 92% respectively of the studied hospitals.The availability of formularies and treatment guidelines were lesser, 46% for both tools.MICs were available at 70 % of the studied hospitals (Figure1).It was observed that both the hospital formularies and antibiotic prescribing guidelines were available in(46%). Most hospitals (70%) had a MIC, with direct access to a database and internet connections as reported by the managerial staff. It seems that the MICs were adequately equipped, yet few of the prescribers were aware of it.

On the other hand; the responses from the prescribers were almost opposite. Few of the medical staff were aware that the hospitals they worked in had PTC (16%) or MIC (21%) units. Likewise, few knew about the presence of hospital formularies (21%), EML (41%) or if the hospital had a list of its own or whether it adapted a STGs or protocols (36%)(Figure2). Among the respondents, consultants, however, seemed more aware of the presence of such tools.

This conflict of responses, between the management and prescribers reflects that these tools might be poorly established, inactive and ineffective. Most of prescribers can not benefit from the rational medicine use tools in the hospitals. The reasons for that might be, poor quality of services, and the fact that the junior medical team lacks education and training in aspects of these RUM tools. Prescribers should be given the appropriate training to enable them


Assessment of the Availability of Tools to Ensure RUM in Khartoum State Public Hospitals

Research Articles6

Abir S. Ali1,Abdalla O. Elkhawad2

Figure 1 Availability of RUM tools in public hospitals in Khartoum State (15 hospitals)

Figure 2 Awareness of prescribers about the availability of RUM tools in public hospitals where they worked


.

Research Articles7

to use and adhere to STGs, protocols, the EML and hospital formularies. Dissemination of these lists and training would improve their utilization. Activating the roles of PTC and MIC will potentially improve the performance of health professionals and provide benefit to patients as well as better management and utilization of resources2.

Conclusion and Recommendations Most hospitals had tools to aid RUM, although they are ineffective because the users lacked the awareness about their existence. There is an apparent need for a multidisciplinary body

to develop, implement, enforce and monitor the use of these tools. Strategies that have been successful elsewhere include education, trainingon RUM tools and provision of adequate funding.

References1. Regional Committee for the Eastern

Mediterranean countries 49th report. 2003: Egypt.

2. AwadA. I.,EltayebI. B, Baraka O. Z. Changing antibiotics prescribing practices in healthcenters of Khartoum State, Sudan.Eur J ClinPharmacol. 2006; 62:135-142

Introduction

Pharmacy and Therapeutics Committee or Medicine and Therapeutics Committee

(PTC) which was formerly referred to as Drug and Therapeutics Committee (DTC) is defined by American Society of Health System Pharmacist as “a committee that evaluates the clinical use of medicines, develops policies for managing medicine use and administration, and manages the formulary system”1.

There are many problems associated with medicine use that necessitates a functioning PTC. Particular areas of inefficiency of medicine use include: poor selection of medicines, inefficient procurement practices, not following the standard treatment protocols in prescribing, poor dispensing practices and patients non- adherence to dosing schedules and treatment advice2.

MethodsThis was a hospital-based descriptive study.PTCs at Khartoum state public hospitals were identified from a list developed by the General Directorate of Pharmacy/Khartoum state, department of Public Pharmaceutical Institutions (GDoP-KRT). Functioning PTCs were included in the study if they have been established or re-established and could be considered as functioning PTC according to the classification set up by GDoP- KRT, which is holding regular meetings. Accordingly 10 hospitals were included in the study.

The study targeted primarily the executive secretary of PTC or their delegates (Clinical Pharmacists or Hospital Pharmacists) in the hospitals. A questionnaire was developed using the Australian Process3; impact and

outcome indicators of PTCs. This tool was composed of semi-structured questions.It was piloted, validated and standardized using WHO guidelines and indicators, before use. Data were analyzed using descriptive analysis.

Results and DiscussionThe study identified 8 functioning PTCs while 2 were excluded because they did not conduct any meetings in 2011.The impact of PTCs and outcome indicators could not be assessed due to lack of data.

The study findings revealed that there were no sufficient tools to aid PTC to function properly in all studied hospitals (Figure 1).The Essential Medicine List was available in only 50% of hospitals. The anti-infective protocols available in the hospitals were:malaria treatment protocol in 87.5% of the hospitals, tuberculosis protocol in 62.5%, and Human Immunodeficiency Virus in 50% of the hospitals.

A drug formulary was developed in 4 hospitals, where 3 had developed a formulary presented as an unbound document containing international non propriety name and therapeutic categorization.

Only one hospital published a manual contain ing the fo l lowing informat ion: international non propriety name, therapeutic categorization, dose/dose adjustment in renal impairment, contraindications, Adverse Drug Reactions (ADRs), dosage form, and suitable diluents for intravenous drugs.

With regards to controlling drug promotion, 2 hospitals had developed a policy for limiting the access of drug representatives. PTCs in collaboration with Medicines Information Centers were involved in conducting teaching sessions on therapeutics in 87.5% of the surveyed hospitals. They also provided


Assessment of the Performance of Pharmacy and Therapeutic Committees in Khartoum State Public Hospitals in 2011

Research Articles8

1. Ahmed Gasim Hospital 2. University of Science & Technology 3. Epi lab, Epidemiological laboratory, Sudan

Hanna Y. Fadul1, Habab K. Elkheir2, 3


Research Articles

9

Figure 1 Availability of tools to aid PTC to function

hospital health workers with detailed written information about medicines available at the hospital and medicines to be purchased.

Only 3 hospitals had developed their own Standard Treatment Guidelines (STGs) covering the following: clinical pathways of pneumonia, upper respiratory tract infections, meningitis,diarrhea, tonsillitis, diabetes mellitus, urinary tract infection and management of asthma.The study identified that no drug utilization studies had been performed to assess adherence to these STGs.

Although a specific form for reporting ADRs was available in 5 hospitals, recording and reporting was implemented in 2 hospitals where there was a nominated professional responsible for ADRs reporting. Within the 2 hospitals that received ADRs reports, only one hospital communicated the information to central levels. None of the surveyed hospitals had reviewed all cases of mortality attributable to preventable ADRs.

ConclusionThe present study revealed that the performance of thePTCs in Khartoum state public hospitals failed to meet the criteria employed in this study probably due to absence of service monitoring and quality assurance.

More efforts are required by the concerned responsible bodies for the development and maintenance of the system through providing financial resources, adequate staff training, guidelines and the necessary support and inspection.

References1. American Society of Hospital Pharmacists. ASHP

statement on the Pharmacy and Therapeutics Committee.Am. J Hosp. Pharm.1992; 49: 648-52.

2. Navarro R.,Managed Care Pharmacy Practice. 2nd edition. USA:David Cella;2009.Availableathttp://books.google.com/books?id=CMj8D5pCrYMC&printsec=frontcover&hl=ar#v=onepage&q&f=false. (Accessed on 05/8/2011)

3. WHO, Indicators for Drug and Therapeutic Committee in Australia, 2008.

Introduction

The risk of drug-drug interactions among patients who are taking multiple drugs is

a serious issue. It is the responsibility of all healthcare professionals to screen, prevent and guard against avoidable drug interactions and predicted side effects.

Multiple drugs are used for management of myocardial ischemia which occurs when there is an imbalance between the supply of oxygen, and other essential myocardial nutrients, and the myocardial demand for these substances1. Drugs prescribed for Ischemic Heart Diseases (IHD) are widely encountered in many healthcare facilities. Most of these prescriptions contain more than one medication for IHD.

Use of these drugs need close monitoring of their potential interactions with other drugs and side effects. Accordingly a combined effort on the level of health providers and patients is necessary. The condition is more serious in Sudan, due to the low level of patients awareness about their diseases, the relationship between their complaints, interactions and serious side effects of medicines used.

The objective of this study was to assess the incidence and severity of potential drug-drug interactions in patients with IHD.

Methods This study was a cross-sectional retrospective/prospective hospital-based study that included 120 patients who visited the cardiology wards of tertiary level hospitals in Khartoum State, Sudan.

Mahmoud M. Mudawi1, 2, Ashraf M. Al-tayeb2, Duha M. Alfatih2.

Prescriptions were checked for potential drug-drug interactions using screening program (multi-drug interactions checker from Medscape) 2. The definitions of the severity of drug interactions were adopted from the same source. Patients included in the study were interviewed using a semi-structured questionnaire about the incidence of adverse effects related to drug therapy.

Results and Discussion Ischemic heart disease patients are among a group of patients who usually suffer other multiple related clinical problems. They are generally older in age and this makes them more prone to multiple chronic diseases and thus multiple medications. Those who are more than 50 years old comprised more than 70% of the sample size.

Drug-drug interactions were identified in 95% of the studied sample. Around 12% of these were severe drug interactions and 78% were moderate drug interactions (Figure 1).

Figure 1: Drug-drug interactions among Sudanese ischemic heart disease patients


Research Articles

Drug-Drug Interactions among Sudanese Patients with Ischemic Heart Disease

10

1. Department of Pharmacology, Faculty of Pharmacy, Omdurman Islamic University, Sudan.2. Departments of Pharmacology, Faculty of Pharmacy, International University of Africa, Sudan.


It is essential to take all necessary precautions to reduce the incidence of these drug interactions by informing the patients of possible interactions among these drugs and the importance of their regular monitoring.

AcknowledgementThis work was supported by the faculty of pharmacy, International University of Africa, Sudan.

References:1. Kumar P. and Clark M. Kumar and Clark Clinical Medicine. 7th ed: Spain: Elsevier Saunders.

2. http://www.reference.medscape.com/drug- interactionchecker; on 10 June 2012.

3. Braunwald E., Antman E.M., Beasley J.W., Califf R.M., Cheitlin M.D., Hochman J.S., et al. A guideline update for the management of patients with unstable angina and non-ST- segment elevation myocardial infarction: a report of the ACC/AHA Task Force on Practice Guidelines (Committee on the Management of Patients with Unstable Angina). J Am Coll Cardiol 2002; 40(7): 1366-1374.

4. http://www.drugs.com/drug_interactions. php; accessed on 10 June 2012.

Research Articles11

The severe and moderate drug-drug interactions explain the complexity of the situation as most of them occurred with drugs that are essential and commonly prescribed to IHD patients.

The majority of severe drug interactions reported in this study were observed in the anti-platelet combinations of aspirin plus clopidogrel (44.7%), aspirin and the anticoagulant enoxaparin (16.7%) and with clopidogrel plus enoxaparin (13.3%). The study revealed that 17.5% of IHD patients experienced bleeding (mainly nasal), which might be attributed to the drug interactions.

Most of the moderate drug-interactions reported in this study were observed in the combinations of aspirin plus the beta-blocker bisoprolol (10.1%) and between the vasodilator, isosorbide dinitrate and bisoprolol(9.1%). The majority of minor drug interactions reported in this study were observed in the combinations of aspirin plus lisinopril (44.1%) and that of the lipid lowering agent atorvastatin plus clopidogrel(41.3%).

The study revealed that 84.2% of the patients were using aspirin which is the most frequently prescribed antiplatelet in IHD patients3. A web based interactions checker reported that a total of 449 drugs interact with aspirin, 68 of these were severe, 309 were moderate and 72 are minor4. The second most frequently prescribed drug in this study; lisinopril (79.2%) interacts with 596 drugs and foods of which 47 were severe while 479 were moderate4.

All patients included in this study had been prescribed multiple medications. In a related study in Nepal, poly-pharmacy was a major factor associated with drug-drug interactions4.

Conclusion and RecommendationsPrescribing multiple medications is common and essential patients with IHD increasing the risk of drug interactions.


News and Updates

News

Published: June 20 2012, Journal of Paediatrics

Published: July 2 2012, BBC Health

Evidence shows that dietary supplements may not benefit children

The indiscriminate use of multivitamins and dietary supplements is considered

by the World Health Organisation (WHO) as an indicator for irrational use of medicines. The use of dietary supplements in children has been shown in a study conducted in the United States (US), to provide inadequate nutrients and sometimes too much nutrients. Researchers analysed data from the US based National Health and Nutrition Examination Survey, 2003-2006. This was a cross-sectional survey that included 7250 children and assessed their dietary intake and use of dietary supplements. The analysis showed that although, the micronutrient intakes in children using dietary supplements were higher than non-users, both groups had inadequate calcium and vitamin D intakes. In some age groups, supplement use was associated with a high possibility of overdosing on micronutrients such as iron, zinc, copper, selenium, folic acid and vitamins A and C. The authors concluded that this study should have implications for reformulation of dietary supplements available for children. However, there is no denying that a varied diet, rich in vegetables, meat and dairy products could provide the essential requirements of micronutrients in children, without resorting to the use of supplements.

Rational use of dietary supplements has shown more benefit in reducing birth abnormalitiesPublished: July 2012 online on British Journal of General Practice.

A study published in the British Journal of General Practice has shown that women who

do not take folic acid in the first trimester of pregnancy have a four fold risk of delivering children with cleft lip or palate. This study was carried out in Ireland where the researchers analysed data from 11,000 full term babies. According to the findings, the incidence of babies with cleft lip or palate was 6.8 in 1000 babies who were not exposed to folic acid. In women who took folic acid, the incidence of delivering a baby with cleft lip or palate decreased to 1.5 in 1000 babies. These findings add to the already strong evidence for the use of folic acid in pregnancy.

GlaxoSmithKline to be fined 3 billion US dollars for unethical promotion of medicines

A report by BBC heal th states that GlaxoSmithKline (GSK), is to plead guilty for the unethical promotion of the drugs Paxil (paroxetine) and Wilburton (bupropion).GSK promoted these drugs for unlicensed uses including the treatment of children and adolescents. GSK will also plead guilty to concealing essential safety data about the diabetes drug Avandia (rosiglitazone) to the US FDA. The drug giant has also been found guilty of bribing doctors:«The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts,» said US attorney Carmin Ortiz

GSK said in a statement that they will settle the libel case by paying the FDA a fine of 3 Billion US dollars as well as agreeing to be under monitoring for the next five years. A spokesman from GSK has stated that the company has learnt lessons from these mistakes and will remove the persons involved in this unethical conduct.

12


PharmacovigilancePharmacovigilance as defined by WHO is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problems.

Pharmacovigilance is mainly concerned with:• Suspected reactions of new medicines.

• Serious or unexpected suspected Adverse Drug Reactions(ADRs) for well-established medicines.

• Increased frequency of a given observed reaction.

• Suspected ADRs associated with drug-drug, drug-food or drug-food supplements.

• ADRs in special groups of interest such medicines use during pregnancy and lactation.

• Suspected ADRs associated with medicine withdrawal, overdose or medication error.

• Lack of efficacy or when suspected pharmaceutical defects are observed.

Pharmacovigilance and post marketing surveillance include the re-evaluation of marketed, risk

management, communicating medicine information, promoting safe drug use and crisis preparedness. It is becoming increasingly important to provide pharmacovigilance services in Sudan because the incidence, pattern, and severity of ADRs may differ due to local environmental and genetic influences.

In Sudan the Pharmacovigilance Department was established in 2007 under the auspices of the National Medicines and Poisons Board (NMPB). The Sudan Pharmacovigilance Department is a member of the Uppsala Monitoring Center (UMC). It is concerned with detection, assessment and prevention of ADRs. The central theme of the department is the demonstration of safety rather than the identification of risks.

Although many medicines have been extensively used in Sudan, their safety and quality profile are not completely studied. We encourage our readers to be involved in reporting ADRs and pharmaceuticals’ quality defects to NMP email:

[email protected] or visit: www.nmpb.gov.sd.

News and Updates

Updates

Published: June 28 2012, Journal of Paediatrics

during 2009 to 2011. Infants hospitalized for acute bronchiolitis were randomized to receive either azithromycin or placebo. The use of azithromycin was not associated with reduced hospitalization or reduced oxygen requirements. The authors concluded that in light of this evidence, azithromycin should not be used in viral bronchiolitis because it would potentially be associated with more adverse events than benefits.

According to a study published in the Journal of Paediatrics, the use of Azithromycin in children with acute bronchiolitis is not associated with better clinical outcomes. Researchers from Brazil enrolled 184 infants into a double-blinded, placebo controlled trial

13More evidence against the use of antibiotics in viral respiratory infections in children


Responding to Requests

of OTC Over The Counter Medicines

Responding to symptoms in the pharmacy is a major role for the pharmacist. On average

a community pharmacist will encounter 10-15 requests for advice about symptoms every day (the actual number varies according to location).

What is responding to symptoms?It is the act of responding clinically to symptoms (health complaints) presented to the care of the pharmacist in a community setting. It includes identifying symptoms, reaching a decision to refer or treat the patient, and ensuring benefit of therapy if recommended.Individuals treat themselves to establish and maintain health, prevent and deal with illnesses, a process regarded in the health community as self-care. Self-care is a wide spread practice that includes: personal hygiene, nutrition, life style and so forth. Socio-economic factors are also involved in self-care. As a result, people may use non- prescribed medication on their own initiative (Self-medication).

Self-care and self-medication are commonly practicedby the public. Pharmacists must ensure that this practice is safe and beneficial to health. People present to community pharmacies requesting treatment for a condition and/or a named product that may happen to be a prescription only medicine (POM).It is the responsibility of pharmacists to personally deal with such cases because they have been equipped with the appropriate knowledge and skills. Other members of the pharmacy team should not ideally be involved in advising people about self- medication/self- care.

How to deal with treatment requests1. Identifythe patient;find out who the patient

is, age and gender. People can request medications on behalf of others.

Guidelines to Good Practices14

Guide for Junior Pharmacists and Pharmacy Students


Guidelines to Good Practices

2. Identify the problem;explore symptoms, signs, their duration and severity. Do not accept the diagnosis of the patient.

3. Take medicine and disease history; determine whether the patient has any other health conditions or using any medicines or home remedies. This includes identifying if the patient has used other medicines for the complaint.

4. Decide to treat or refer. Only minor conditions can be treated in the pharmacy. Infections and serious complaints MUST be referred to medical care. However, some help might be appropriate from the pharmacist before the patient gets to medical care centers.

5. Advice and counsel; explain to the patient your decision. It is useful to provide an explanation about the initial complaint and the role of therapy. Nonpharmacological measures may need to be recommended.

Here is mnemonic to help you remember how to deal with treatment requests: WWHAMW: Who is it for?W: What is it for?H: How long have the symptoms persisted?A: Action taken: what medicines have you already tried?M:Medicines used for other diseases.Antimicrobials (antibiotics, antimalarial, anthelmintic…) should never be dispensed without a prescription.

The pharmacist can dispense medicines from the OTC list freely but should never dispense POM in response to requests by patients.

Counseling patients on medicines

The purpose of counseling is to:1. ensure that patients are adequately

informed about their medication 2. pre-empt and identify any problems which

might cause loss of efficacy of medications

15How to go about counseling1. how and when to take and use the medicine2. how much to take or use the medicine3. how long to continue4. warn the patients on serious adverse

reactions likely to occur and what to do if such thing goes on

5. how to recognize side effects and minimize their incidence

6. life style and dietary changes which need to be made

The above is the general procedure for undergoing any patients counseling but further advice might be needed for other groups like children, elderly, people with physical disabilities, pregnant ladies and those of chronic illness.

Aids to counselingPatient information leaflets and warning cards are useful aids when giving advice to patients

Example:Advice to patients on Diclofenac tablets• Diclofenac is used to relieve pain, particularly

pain in the muscles and joints. • The tablets/capsules should be swallowed

whole with a drink of water or milk, not crushed or chewed.

• Avoid taking indigestion remedies for at least one hour before and after taking diclofenac. They can affect the special coating that makes the diclofenac work most efficiently.

• Some people have indigestion after taking diclofenac. To prevent this, diclofenac should be taken with or just after food. If indigestion or heartburn persists, you should contact your doctor.

• Other side effects that occasionally occur with diclofenac include diarrhoea, feeling sick, headache and dizziness. If you have severe indigestion (stomach pain), difficulty in breathing or a skin rash, stop taking the medicine and contact the doctor straight away.

• Problems can occur if diclofenac is taken with some other medicines. Are you taking any other prescribed medicines or medicines you have bought?

Proper use of Metered Dose I n h a l e r s

Metered dose inhalers are used to manage chest problems. It is

critical to use them properly to ensure the accurate delivery of medicines to the lungs. The following steps should be clearly explained to the patient. It is recommended that patients should be asked to demonstrate their ability to follow these steps before leaving the pharmacy. In certain circumstances, patients who are using corticosteroid inhalers or, unable to use inhalers should be given a spacer.

1. Wash your hands thoroughly with soap and warm water.

2. Remove the cap and hold the inhaler upright.

3. Shake the inhaler.

4. Breathe out slowly through your mouth.

5. Hold your inhaler as shown in the picture.

6. While you are breathing in, press down on your inhaler one time to release the medication.

7. Continue to breathe in slowly and as deeply as you can.

8. Hold your breath for 10 seconds, if you can, to allow the medication to reach deeply into your lungs.

9. Repeat steps 3 to 8 until you have inhaled the number of puffs that your doctor prescribed. Ask your doctor or pharmacist if you need to wait between puffs of your medication.

10. Rinse your mouth thoroughly with water.

11. Spit out the water. Do not swallow.

How to Use Metered-Dose Inhalers

Shake the inhaler.

Wash your hands thoroughly with soap and warm water.

Breathe out slowly through your mouth.

While you are breathing in, press down on your inhaler one time to release the

medication.


Useful Tips16


Multi-disciplinary Approach to achieve Rational Use of Medicine

Q:We heard that the WHO recommended the formation of a national multidisciplinary body to coordinate the Rationale Use of Medicine (RUM) policies, so who should be involved in this body?

A:This body varies from country to country, but in all cases it should involve representatives from governmental (Ministry of health) bodies, the health professions, academia, regulatory authority, pharmaceutical industry, consumer groups and non-governmental organizations.

Q: What is the importance of the multidisciplinary approach in achieving RUM?

A:The involvement of key stakeholders ensures the success of implementing the interventions and strategies of RUM. Multidisciplinary interventions have been shown to have a better impact than single disciplinary interventions.

Q: What are the activities of the multi disciplinary team in promoting RUM?

A: They are responsible for developing and implementing medicines policies, treatment guidelines, hospital formularies, training and continuous professional development curricula.

Q: Can you give an example to further illustrate the types of activities where multidisciplinary approaches are involved?

A:The Pharmacy and Therapeutics Committee (formerly known as the Drugs and Therapeutics Committee) is an example.

Q&A

Questions and Answers

Different healthcare providers (physicians, pharmacists, nurses, administrative staff) collaborate together to prepare and implement Standard Treatment Guidelines.

Q:What is the role of the prescriber in the multidisciplinary team?

A:Prescribers are involved in selection of medicines to be included in the hospital formulary and adopting treatment guidelines in their daily practice. Prescribers assume the full responsibility for patient care. Junior prescribers carry out the day today care issue such as assessment and changes of medication.

Q:How can a pharmacist contribute to the multidisciplinary team?

A:Pharmacists provide appropriate information, and instructions regarding the adverse drug reactions, dosage schedule of drugs to the patients and warning them about the unwanted effects of medicines and monitoring such unwanted effects. They are also involved in educating the patient about the hazards of self-medication, over use of drugs and poly-pharmacy.

Q:How can a nurse contribute to the multidisciplinary team?

A:Nurses ensure that patients receive their medicines following the proper steps of medicine administration. They can be involved in identifying medication errors, dose monitoring and monitoring response.

.

17

Irrational use of medicines is a widespread problem at a l l levels of heal thcare,

especiallyin hospitals. This is particularly worrying as resources are generally scarce and prescribersin communities often copy hospital prescribing practices. Use of medicines can be greatly improved if some simple principles of drug management are followed. However, it is difficult to implement these principles because staffs from many different disciplines are involved, often with no forum for bringing those together to develop and implement appropriate medicines policies.A PTC provides such a forum, allowing all the relevant people to work together to improve healthcare delivery, whether in hospitals or otherhealth facilities. In many developed countries a well-functioning PTC has been shown to be very effective in addressing drug use problems. However, in many developing countries PTCs do not exist and in others they do not function optimally, often due to lack of local expertise or a lack of incentives.

Why are PTCs needed?Essential medicines are one of the most cost-effective ways of saving lives and improving health, and constitute 20–40% of health budgets in many developing countries. Increasing costs and lack of resources often result in public health systems being unable to procure sufficient medicines to meet patient demand. Particular areas of inefficiency and druguse problems include:• Poor selection of medicines, without

consideration for relative efficacy, cost-effectiveness or local availability.

• Inefficient procurement practices, resulting in non-availability, inadequate quality wastage or use of unnecessarily expensive medicines.

• Prescribing not in accordance with standard treatment protocols.

• Poor dispensing practices, resulting in medication errors and patients’ lack of

knowledge about dosing schedules.• Patients not adhering to dosing schedules

and treatment advice.Goals and objectives of the PTCThe goal of a PTC is to ensure that patients are provided with the best possible cost-effective quality of care through determining what medicines will be available, at what cost and how they will be used.In order to achieve this goal a PTC will have the following objectives:• To develop and implement an efficient and

cost-effective formulary system.• To ensure that only efficacious, safe, cost-

effective and good quality medicines are used.

• To ensure the best possible drug safety through monitoring and evaluation.

• To develop and implement interventions to improve medicine use by prescribers, dispensers and patients.

Functions of the PTCThere are many possible functions of a PTC, and the committee must decide which to undertake as a priority; this decision may depend on local capacities and structure.Furthermore, certain functions will require liaison with other committees or teams, for example the infection control committee or the procurement team.Structure and organization of a PTCIt may be easy to have a list of core and additional members, all with different expertise, objectives and functions, but it is very difficult to ensure that it functions effectively. Success will depend on having strong and visible support from the senior hospital management and abiding by the following principles:• Multidisciplinary approach sensitive to local

politics• Transparency and commitment to good

service• Technical competency and administrative

support

Educational Materials


18Pharmacy and Therapeutic Committees (PTCs( or Drug and Therapeutic Committees (DTCs(



Examples of PTC functionsA. Investigating the use of medicinesThe first step to addressing problems of irrational use of medicines is to measure the problem,analyze it and understand the causes underlying it. There are four main methods, all of which should be regularly used by PTCs.1. Aggregate data methods involve data that do not

relate to individual patients and can be collected relatively easily. Methods such as ABC analysis, Vital Essential and Nonessential (VEN) analysis and DDD methodology are used to identify broad problem areas in drug use.

2. Drug indicators studies involve collecting data at the level of the individual patient but do not usually include sufficient information to make judgments about drug appropriateness for diagnosis.

3. Qualitative methods such as focus group discussion, in-depth interview, structured observation and structured questionnaires are useful for identifying why drug use problems occur.

4. Drug use evaluation is a system of ongoing criteria-based evaluation of drug use that will help to ensure appropriate use at the individual patient level. This method involves the detailed analysis of individual patient data

B. Promoting the rational use of medicinesChanging the use of medicines to ensure that they are used in the most effective way is theoverall aim of a PTC. There are three overall types of strategy to change the use of medicines:1. Educational strategies that aim to inform prescribers• In-service education programs, workshops,

seminars.• Drug information resource center/unit.• Drug newsletters and bulletins.• Formulary manual and Standard Treatment

Guidelines(STGs).2. Managerial strategies that aim to guide the decisions of prescribers• Developing and implementing STGs.• Audit and feedback.• Clinical pharmacy programs.• Medicine restrictions.• Avoiding perverse financial incentives.

3. Regulatory strategies that aim to restrict the decisions of prescribers• Supporting national regulations.• Hospital policy on pharmaceutical

promotion.A comprehensive approach with a combination of interventions (preferably of different types) is always more effective than single interventions. It is critical to assess the impact of interventions using adequate study design.

Steps in setting up and managing the PTCSTEP 1: Organizing the committee and selecting membersMembersshould be selected with reference to their positions and responsibilities andthey should have defined terms of reference. In most hospitals, the membership includes:• A representative clinician from each major

specialty, including surgery, obstetrics andgynecology, internal medicine, pediatrics, infectious diseases and general practice.

• A clinical pharmacologist, if available.• A nurse, usually the senior infection control

nurse or sometimes the matron.• A pharmacist (usually the chief or deputy chief

pharmacist) or a pharmacy technician where there is no pharmacist.

• An administrator representing the hospital administration and finance department.

• A clinical microbiologist or a laboratory technician where there is no microbiologist.

• A member of the hospital records department.• Other members may also be included for their

particular expertise, for example a medicine information specialist, quality assurance specialist or consumer group representative.

STEP 2: Determine the objectives and functions of the committeeIt is not possible for a PTC to do everything. The first thing a PTC should do is to agree it’s terms of reference, which specify the PTC’s place in the organizational structure of the hospital, its goals, objectives, scope of authority, functions and responsibilities.

19



. 20

STEP 3: Determining how the committee will operate• Regular meetings of the PTC, at least

quarterly.• Regular attendance.• The agenda, supplementary materials and

minutes of the previous meeting should be prepared and distributed to members by the secretary.

• All PTC recommendations should be disseminated to the medical staff and other concerned parties in hospital. Regular hospital activities such as grand ward rounds and clinical discussions can be used as venues to disseminate information.

• All PTC operating guidelines, policies and decisions should be documented. Relevant documentation must be made available.

• Liaison of the PTC with other hospital committees and regional or national committees is important.

STEP 4: Seeking a mandateOnly with a mandate from the most senior authority in the hospital is a PTC credible andsustainable. The mandate of a PTC should specify:• Its roles and functions.• Its place in the organizational structure.• Its membership.• Its scope and lines of authority.The strongest mandate a PTC can have is that issued by the government.STEP 5: Identifying budgetary sourcesThe PTC must be able to identify budget resources to support its own activities (such as meetings or incentives for its members) and those activities it recommends for implementation (for example, educational programs, development of standard treatment protocols, drug utilization review and supervision). The PTC should be able to demonstrate its own cost-effectiveness when requesting a regular budget allocation from the hospital management. To this end, the PTC should prepare an annual action plan with corresponding budget requirements. It is more convincing to present budgetary requirements together with past or potential future cost savings.

STEP 6: Forming sub-committees to address specific issues

STEP 7: Assessment of the DTC’s performanceSelf-assessment and evaluation of the PTC are very important if performance and impactare to be improved. The organizational development and performance of the PTC should be monitored continuously and documented, especially if the PTC expects the hospital management to provide continuing funds.Getting startedPTCs can nearly always be started or their functioning improved by demonstrating a drug use problem to the major stakeholders and senior prescribers, and then planning with them what to do about it. The plan should include:• Measuring the problem quantitatively• Investigating the problem qualitatively to

understand underlying reasons for the problem• Developing and implementing an intervention

to correct the problem• Measuring the drug use problem again in order

to evaluate the intervention.Revitalizing non-functioning PTCsMany PTCs do not function. The way to address this is very similar to starting up a PTC from scratch. Often PTCs do not function because there is:• Lack of awareness of medicineuse problems or interest to address these problems.• Lack of awareness of what a PTC could do to address medicine use problems.• Lack of time or reward for members to undertake any PTC activities.

Instructions to authorsScope of the Journal: Rational use of medicines related to health care providers and patients.

Suitability of publication:All topics related to the different aspects of RUM will be evaluated by the editorial board. Prospective authors with a subject(s) or questions about the suitability of their papers or materials are invited to request an opinion from the Editorial Board. ([email protected]).

Avoid plagiarism

How to submit materials:Manuscripts can be handed over directly to the editor-in-chief as soft copy or by e-mail ([email protected]).

Types of manuscripts:1. Research papers.2. Case reports.

Preparation of manuscriptsAll manuscripts must be typed in Arial font size 12, with 1.5 line spacing. Manuscripts must be in Word. Page margins on all sides must be at least 2.5 cm wide. You can use either English or American spelling but not both on the same manuscript.

1. Research papersOriginal research will have the priority of publications. Author(s) name and affiliations should be clearly written. Contact person, telephone number and e mail address should be included. Total words count should not exceed 800 words including references, tables, table captions, figure legends, and footnotes. Maximum of three tables and figures are accepted.

The manuscript should be divided into sections. Each section should have a separate heading. Subheadings take the form of paragraph lead-ins (should be bold case), indented and run in with the text, separated by a period.

Introduction:This section should provide the reader with sufficient background information to evaluate the results of the research. An extensive review of the literature is not needed in this section. It should also give the rationale for and objectives of the study that is being reported.

Methods: Sufficient information must be provided so that the reader will understand the methodology and be able to repeat the experiment.

Results: The results section should be written in such a manner to provide information by means of text, tables and figures. Results and discussion may be combined or there may be a separate discussion section. If a discussion section is included,place extensive interpretations of results in this section. Do not repeat the results. Give numbers to figures and tables in the order in which they are mentioned in the text. All figures and tables must be cited in the text.

Conclusions and recommendations: Acknowledge personal, financial and institutional assistance at the end of this section.

References: Use the Vancouver reference system.Cite 6 references maximum.

2. Case reportsAny case that is related to RUM will be considered. The manuscript should include the following:

Setting, complete description of the case, consequences and outcome and finally follow up if applicable. Words count should not exceed 400 words.

NOTE: Ethical clearance is a requirement for all researches from 2012 onward.

JS

Sudan Jornal of Rational Use of Medicine

Republic of SudanFederal Ministry of HealthDirectorate General of PharmacyNational Medicines Information Centre and Reference LibraryAlgama StreetTel. 0183749255, 0183772843Fax: 0183749256Website: www.nmicrl.sd www.sjrum.sd Email: [email protected] staffSarah A. Kareem Hassan B. Pharm, M. Pharm, MBA Badreldin Said Hagnour B. Pharm, FPSMEman Ahmed Dahab B. Pharm

© All Right Reserved for DGoP 2013

• Well trained Staff to answer enquiring with most recent computer programmed and Hard copies library

• Different Activities To Medical staff as lectures, seminar, workshops and training courses• Publication and reprinting to most recent medicine information and clinical guidelines• Promotes Rational use of medicines through public mass media• Scientific research to most related problem to the field and the community

Drug Information Centre Gezira State Established in 2004 to provide

independent medicines information to health care providers and public

Contact Information and location:E mail: [email protected]: 0912320267 - 0122135863 - 01238090190122644331 - 0118539059 - 0122043399

J

sudan journal of rational use of...

Documents