Ethiopian Reproductive, Maternal, Newborn and Child Health (RMNCH) Medicines Formulary

Contents

Acknowledgements

Acronyms and Abbreviations

Background

Structure and How to Use the Formulary

Sources of RMNCH Medicines Formular

Prescribing, Dispensing and Patient Counseling Practices

Medicine Use in Pregnancy, Breast Feeding, Infants/Children, Renal/Hepatic Diseases

Antimicrobials Use and Resistance

Adverse Drug Reactions

Priority Life-Saving Medicines for Women and Children

I. Medicines for Children Under Five
1. Medicines Used in Diarrhea
2. Medicines Used in Intestinal Helminthiasis
3. Medicines Used in Intestinal Protozoal Infections
4. Medicines Used in Malaria for Children
5. Medicines Used in Neonatal Sepsis
6. Medicines Used in Pain and Palliative Care
7. Medicines Used in Pneumonia
8. Medicines Used in Prevention of Mother-To-Child Transmission of HIV (PMTCT)
9. Co-trimoxazole Preventive Therapy (CPT)
10. Medicines Used in Prevention of TB in a Newborn
11. Medicines Used in Severe Acute Malnutrition
12. Medicines Used in Trachoma
13. Medicines Used in Umbilical Cord Infection
14. Medicines Used in Vitamin A Deficiency
15. Vaccines Used in Expanded Program of Immunization (EPI)

II. Medicines for Women
1. Medicines Used in Abortion
2. Medicines Used in Anemia During Pregnancy
3. Medicines Used in Hyperemesis During Pregnancy
4. Medicines Used in Hypertensive Disorders During Pregnancy
5. Medicines Used in Infertility
6. Medicines Used in Maternal Sepsis
7. Medicines Used in Postpartum Hemorrhage
8. Medicines Used in Preterm Labour Management
9. Medicines Used in Sexually Transmitted Infections (STIs)
10. Medicines Used in Treatment of HIV for Pregnant Women
11. Medicines Used in Treatment of Malaria for Pregnant Women
12. Medicines Used in Treatment of TB for Pregnant Women
13. Medicines Used in Vaginal Candidiasis
14. Tetanus Toxoid Immunization for Women of Childbearing Age
15. Contraceptives
16. Miscellaneous

Appendixes

Indexes

Preface

Independent and up-to-date medicines information is essential for the safe and effective use of medicines. Recognizing this need, the Ethiopian Food, Medicine and Healthcare Administration and Control Authority (EFMHACA) has been developing and disseminating medicines information materials including, formularies and standard treatment guidelines, good prescribing and dispensing manuals and bulletins in print copies and through its website www.fmhaca.gov.et in electronic copies.

In line with this, the Ethiopian Reproductive, Maternal, Newborn and Child Health (RMNCH) Medicines Formulary is the first of its kind that aims to provide formulary information on life saving medicines which can prevent leading causes of morbidity and mortality in women and children when used properly. The RMNCH medicines formulary contains key medicines information which is essential for good prescribing, dispensing, administration and use of medicines and it can be used by all health care professionals providing RMNCH service.

We hope that this formulary will be helpful in improving

the health of mothers and children through promoting the rational use of medicines in the provision of quality health services. The RMNCH formulary will be used for rapid reference and it may not always include all the information needed in maternal and child health and also does not substitute standard treatment guidelines. With this, it gives me a great pleasure to introduce the first edition of the RMNCH medicine formulary to all beneficiaries.

Finally, I would like to take this opportunity to thank all members of the task force, consultants, experts and institutions for their valuable input in the development of this formulary.

Acknowledgements

This first edition of the Ethiopian RMNCH Medicines Formulary has passed through intensive formulary development stages of selection of medicines, preparation of draft document, consultative workshops, and finalizing the document by incorporating valuable comments. The draft document was prepared by consultants who are experts in the field. Then it was first commented and enriched by a taskforce selected from different stakeholders led by FMHACA. Further comments and suggestions were obtained at a consultative workshop comprising of Federal Ministry of Health, Regional Health Bureaus, relevant professional associations, universities, public and private hospital practitioners, partners, PFSA and FMHACA. Once the comments have been incorporated, it was edited, formated and finalized by the taskforce and consultants.

FMHACA would like to thank members of the taskforce, team of consultants, FMHACA Advisory Committee, and all individuals and institutions that participated in the consultative workshop and provision of comments.

The names of individuals are annexed. Our special gratitude also goes to USAID/SIAPS for its continued technical and financial support including expenses of consultants, workshops and printing.

Acronyms and Abbreviations

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Background

Improving maternal and child health is a global priority. The global mortality rate of women and children under five years remains a significant and inequitable problem. It galvanized political leadership, attracted new financial commitments, and created “Every Woman Every Child” movement. Several global goals, action plans and strategies were launched to address major problems of women’s and children and bring attention for country implementation. In doing so, millions of lives were saved and progress towards achieving the Millennium Development Goals (MDGs) were made. Increasing access to family planning products and services, targeting major killers of mothers and children, combating HIV/AIDS, malaria and tuberculosis, and improving malnutrition were successful intervention areas in the past years.

However, far too many women, children and adolescents worldwide still have little or no access to essential, good-quality health services and medicines. As a result, the annual maternal, children, newborn and adolescent deaths remain unacceptably high. Ethiopia has achieved the MDG goals in reducing maternal and child deaths by 69% and 67% from the 1990 estimates respectively. However, Ethiopia is still one of the six countries sharing 50% of total world burden of maternal mortality of 420 per 100,000 live births in 2013. Hemorrhage (25%), Hypertension (16%), Sepsis (10%) and Abortion (10%) were the leading causes of mortality in 2013. According to the 2014 demographic and health survey report, the total under- five deaths were 205,000; where neonatal and infant mortality rate accounted 29 and 47 per 1,000 live births respectively. Pneumonia (16%), Diarrhea (9%) and Sepsis (9%) were the main causes of under-five deaths in 2012.

Majority of maternal and under-five child deaths can easily be prevented or treated using a few essential medicines and supplies and providing education and training to the frontline health workers on simple and life saving techniques. With the high level of pregnancy, childbirth related and under-five deaths, achieving optimal maternal and child health has become the responsibility of all health personnel at all levels of care. Medicines, when used correctly, they can offer simple and cost-effective solutions to many health problems. Today many people have little or no access to safe and effective drug therapies and may be at risk of serious health problems. This is particularly important during pregnancy where it holds a double risk. Interventions targeted at ensuring good prescribing and dispensing practices are critical to improve Reproductive, Maternal, Neonatal and Child Health.

Appropriate use of medicines for maternal and child health is a shared responsibility of the health system, prescribers, dispensers, and end-users. Clinical judgments should be supported when possible, by valid and clinically useful evidence that is likely to result in improved outcomes. Unfortunately, many healthcare professionals lack access to up-to-date and unbiased information regarding medicines and their proper use. Formularies contain clinically oriented summaries of pharmacological information about selected medicines that can promote good prescribing and dispensing practices so as to ensure rational medicine use.

Cognizant of this fact, FMHACA has developed the first edition of a formulary for selected life saving RMNCH medicines. The objective of the formulary is to provide specific and up-to-date medicines information through a formulary monograph which will support appropriate prescribing, dispensing and use of selected medicines in the management of common causes of morbidity and mortality in RMNCH. It will be utilized by health care professionals providing services to mothers, children, newborns and adolescents at different healthcare facilities. The formulary, apart from being used as desk reference, it can also be used as a resource material during trainings of health care providers who specifically deal with RMNCH services.

The scope of this formulary is to provide basic information only on life-saving medicines needed for RMNCH problems that will have the biggest impact on reducing maternal, newborn and child morbidity and mortality. Omission of a particular medication does not necessarily indicate that it is not available or recommended; merely that it is not considered a priority medicine for RMNCH. This formulary by no means substitute standard treatment guidelines and national treatment protocols issued in the area of RMNCH. For detailed information on diseases and their management, treatment guidelines and protocols should be consulted.

Structure and How to Use the Formulary

Before the main text of the formulary, there are important general information on prescribing, dispensing and patient counseling practices; medicine use in pregnant women, breast feeding mothers, infants/children, renal and liver disease; antimicrobial use and resistance and adverse drug reactions and reporting. List of life-saving medicines for women and children under five with their specific dosage forms and strengths is presented that can facilitate easy identification and follow up of these life saving medicines.

The main content of the formulary is presented by indication, divided in to 23 main chapters. Following each indication, monograph of each medicine by generic name is organized except in few chapters that contain sub-indications before medicine monographs. Within each medicine monograph, the following information is included: dosage form and strength; indications; precautions; drug interactions; contraindications; side effects; dose and administration and storage condition of the dosage form. Additional notes are included at the end of each medicine as necessary. While severe drug interactions are listed within the main text of each medicine, other non-severe interactions together with the severe ones are included in the appendix section with full description. Side-effects are listed in order of frequency, when known. The probability or chance of experiencing side effects are characterized as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and frequency not known. The formulary have appendix information and it is indexed by both diseases/cases and medicines.

Sources of RMNCH Medicines Formulary

While preparing this formulary, international and national sources were consulted. This includes but not limited to: WHO priority life-saving medicines list for women and children under five; Ethiopian National Essential Medicine List 2014; UN Priority life saving commodities for women and children; Integrated management of newborn and childhood illness; Latest editions of British National Formulary for adults and children; WHO model formulay for children and adults; Latest Ethiopian medicines formulary; Latest standard treatment guideline for general hospitals in Ethiopia; Ethiopian national expanded program on immunization strategy and guideline; Latest national malaria guideline; National guideline for the management of STI using syndromic approach; Latest national guideline for comprehensive HIV prevention, care and treatment; Management protocol on selected obstetrics topics for health centers in Ethiopia; Management of major mortality drivers of mothers and neonates using MNH essential commodities in Ethiopia; WHO and Ethiopian pediatric hospital care pocket book: guidelines for the management of common illnesses in hospitals. Ethiopian Health Sector Transformation Plan; National Newborn and Child survival strategy document brief summary; The global strategy for women’s, children’s and adolescents’ health; count down to 2015, fulfilling the health agenda for women and children: the 2014 report, Ethiopia; WHO Recommendations for Prevention and

Treatment of Pre-eclampsia and Eclampsia;

Hypertension in pregnancy by The American College of Obstetricians and Gynaecologists (2013); The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, JNC 7; The Diagnosis and Management of Pre- eclampsia and Eclampsia clinical practice guideline by Institute of Obstetricians and Gynecologists Royal College of Physicians of Ireland (2013); Goodman & Gilman's: The Pharmacological Basis of Therapeutics; American hospital formulary system (AHFS); Applied therapeutics: the clinical use of drugs; Guidelines For Clinical and Programmatic Management Of TB, TB/HIV And Leprosy In Ethiopia.

Prescribing, Dispensing and Patient Counseling Practices

Good Prescribing Practices: A prescription serves as a means of communication among the prescriber, dispenser and medicines consumer pertaining to treatment or prophylaxis. While prescribing for children and women, prescriptions should be written on a standard prescription paper, legibly in ink, should be dated, should state the full name and address of the patient, should state diagnosis, and should be signed in ink by the prescriber. The age of the child should preferably be stated. The prescriber should state the current weight of the child to enable the dose prescribed to be checked. Consideration should also be given to include the dose as mg/kg or as mg/m² where this would reduce error.

The names of drugs should be written clearly and not abbreviated, using generic name. The strength or quantity to be contained in capsules, tablets, etc. should be stated by the prescriber. In particular, strengths of liquid preparations should be clearly stated (e.g. 125 mg/5 mL). When the dose of liquid preparations ordered is smaller than 5 mL an oral syringe should be supplied. Doses for children are generally based on body-weight, age or body surface area. Directions specifying the route, dose and frequency should be clear and explicit.

Drugs should be prescribed in pregnancy only if the expected benefit to the mother is thought to be greater than the risk to the fetus, and all drugs should be avoided if possible during the first trimester. This, however, should not preclude the importance of prescribing in life threatening conditions of the mother. Drugs which have been extensively used in pregnancy and appear to be usually safe should be prescribed in preference to new or untried drugs; and the smallest effective dose should be used. Preconception medication review for patient with chronic diseases and on drug therapy is a good practice. During prescribing, the information mentioned under medicines use for pregnant women, breast feeding mothers, infants and children, antimicrobial use and good prescribing practices manual, shall be referred.

Good Dispensing Practices: Good dispensing practices

ensure that the correct drug is delivered to the right patient, in the required dosage and quantities, with clear information, and in package that maintains an acceptable potency and quality of the drug. Dispensing includes all the activities that occur between the times the prescription or oral request of the patient or care provider is presented and the medicine is issued. Any error in the dispensing process can seriously affect the care of the patient mainly with health and economic consequences. During medicines dispensing and counseling, good dispensing practices manual and medicines dispensing and counseling guides are recommended resources to use.

Counseling of Patients: Counseling should be tailored to the age, experience, background, and patient medical conditions. The prescriber and the patient should agree on the health outcomes that the patient desires and on the strategy for achieving them. Taking the time to explain to the patient (and careers in case infants and children) the rationale and the potential adverse effects of treatment may improve adherence. The pharmacist should reinforce and elaborate the physician’s instructions. For example, for contraceptive user, a provider should explain to the woman about the advantages and disadvantages, the benefits and risks, effectiveness, importance of adherence, relevant drug interactions, common and serious side effects, management of side effects and when to seek immediate medical attention.

Counselling of women before a planned pregnancy should be carried out, including discussion of risks associated with specific therapeutic agents, traditional medicines, and abuse of substances such as nicotine and alcohol. For women with chronic diseases and on drug therapy, preconception counselling and medication review is good practice. (eg.,women with chronic hypertension and a previous pregnancy complicated by preeclampsia, preconception counselling on how to prevent preeclampsia or reduce its severity is important). Furthermore, preconception use of folic acid to reduce neural tube defects is advisable. During pregnancy women should be advised to avoid self medication.

Breast feeding mother should be advised to avoid self medication, on prevention of mother to child transmission if HIV positive, also be informed about importance of timely immunization of the infant. Parents or careers must be warned to keep all medicines out of reach of children.

Medicine Use in Pregnancy, Breast Feeding, Infants/Children, Renal/Hepatic Diseases Medicines Use for Pregnant Women: The kinetics of drug is altered during pregnancy. The rate of absorption decreases, while volume of distribution, metabolism and glomerular filtration rate increase during pregnancy. The embryonic period, where, organogesis takes place, is the most susceptible period of pregnancy to drug effects. Administration of drugs, except those proved to be safe, in the first trimester, is therefore not generally recommended. It is advisable not to prescribe any drug during at any stage of pregnancy, if possible. This, however, should not preclude the importance of prescribing in life threatening conditions of the mother.

Prior to prescribing any drug for pregnant women, the benefit-risk ratio of giving should be considered. For safety of medicines during pregnancy, See Appendix 2. Medicines Use for Breast Feeding Mothers: Most drugs administered are detectable in breast milk. The concentration, however, is low. If the woman has to take the drug and the drug is relatively safe, she should optimally take it 30-60 minutes after nursing, and 3-4 hours before next feeding in order to allow time for many drugs to be cleared from the mother’s blood, and the concentration in breast milk to be relatively low. Drugs for which no data are available on safety during lactation should be avoided or breast feeding discontinued while they are being given. Most antibiotics taken by nursing mothers can be detected in breast milk e.g., tetracycline and chloramphenichol. Most sedative hypnotics achieve concentrations in breast milk. Opioids also achieve concentrations in breast milk. Antineoplastic drugs are contraindicated in breast feeding. So it is worth noting not to give drugs secreted in milk to the nursing mother. For safety of medicines during breast feeding, See Appendix 3.

Medicines Use for Infants/Children: Physiologic processes that influence drug kinetics in the infant change significantly in the first year of life, especially the first few months, while there is no much difference in the dynamics. Gastro intestinal (GI) enzymes are lower in the neonates than in adults. So drugs, which are partially or totally inactivated by the low pH of gastric content, should not be administered orally. Neonates have less bile acid so that absorption of lipid soluble drugs is less. Gastric emptying time is prolonged in the first day. So drugs, which are absorbed primarily in the stomach, may be absorbed more completely. For drugs absorbed in the small intestine, therapeutic effects may be delayed. Peristalsis in neonates is slow. More drugs, therefore, will get absorbed from the small intestine. The volume of distribution is low in children, and drug metabolizing enzymes are not well developed. The glomerular filtration rate is slower than adults (30-40%). So the clearance of drugs is slower in children than in adults. This definitely demands for dose adjustment in this age group.

Doses for children are generally based on body-weight, age or body surface area (Appendix 4). The following age ranges are often used: first month (neonate); up to 1 year (infant); 1-6 years (young children); and 6-12 years (older children). For most drugs the adult maximum dose should not be exceeded. For example if the dose is stated as 8 mg/kg (max. 300 mg), a child weighing 10 kg should receive 80 mg but a child weighing 40 kg should receive 300 mg (rather than 320 mg). Body surface area (BSA) estimates are sometimes preferable to body- weight for calculation of pediatric doses since many physiological phenomena correlate better with body surface area.

Medicines Use in Renal Failure: Many drugs are excreted through the kidneys and impairment of renal function alters the excretion of these drugs and may result in renal as well as non renal toxicity unless doses are adjusted on the basis of the degree of renal impairment. For dose adjustment in renal failure, it may occasionally be necessary to measure drug levels and adjust doses accordingly. Factors that potentiate renal dysfunction and contribute to the nephrotoxic potential of renally excreted drugs include: intravascular volume depletion either due to external losses or fluid sequestration (as in ascites or edema); concomitant use of two or more nephrotoxic agents e.g. Nonsteroidal anti-inflammatory agents, aminoglycosides, radio contrast agents.

In general, in the presence of renal impairment, to avoid worsening of renal dysfunction: Avoid potentially nephrotoxic drugs and use alternative drugs that are excreted through other routes. If there are no alternative drugs to use, adjust the dose. Dose adjustment may be accomplished in three different ways: Decreasing each individual dose and maintaining the same dose frequency; Maintaining the same individual dose but administering each dose less frequently; and Modifying both individual doses and the frequency of administration, which is a combination method; Ensure that the patient is adequately hydrated; If the patient is on dialysis check if the drug is eliminated by the specific dialysis modality and consider administering a supplemental dose at the end of the dialysis session; and Serially monitor kidney function.

Medicines Use in Liver Disease: The liver is a site for the metabolism and elimination of many drugs but it is only in severe liver disease that changes in drug metabolism occur. Unfortunately, routine determination of liver enzymes and other tests of liver function cannot predict the extent to which the metabolism of a certain drug may be impaired in an individual patient. In general, drug prescription should be kept to a minimum in all patients with severe liver disease. Major problems occur in patients with advanced liver disease who have ascites, jaundice or hepatic encephalopathy. The hypoproteinemia in patients with severe liver disease is associated with reduced protein binding and with increased toxicity when highly protein bound drugs are used. One must exercise caution in the use of some drugs like sedatives, opioids and diuretics which may precipitate hepatic encephalopathy in patients with advanced liver disease. It is always advisable to consult tables in standard textbooks or drug formularies before prescribing drugs for patients with severe liver disease.

Antimicrobials Use and Resistance

Appropriate use of antimicrobials is the cost-effective use which maximizes therapeutic effect while minimizing both drug-related toxicity and the development of antimicrobial resistance. The general principles of appropriate antimicrobial use are the same as those for all other medicinal products. An additional dimension for antimicrobials is that therapy for the individual may affect the health of society as a result of the selective pressure exerted by all use of antimicrobial agents. In addition, therapeutic failures due to drug- resistant pathogens or super infections lead to an increased potential for the spread of these organisms throughout hospitals and the community. Although these risks occur even when antimicrobials are used appropriately, inappropriate use increases the overall selective pressure in favour of drug-resistant microorganisms.

The choice of an appropriate antimicrobial agent may be straightforward when the causative pathogen(s) is/are known or can be presumed with some certainty from the patient’s clinical presentation. However, in the absence of reliable microbiological diagnosis or when several pathogens may be responsible for the same clinical presentation, empiric treatment, often with broad-spectrum antimicrobials, is common. Ideally, the choice of antimicrobial should be guided by local or national resistance surveillance data and treatment guidelines. The reality is often far removed from this ideal.

Resistance to antimicrobials is a natural biological phenomenon. The introduction of every antimicrobial agent into clinical practice has been followed by the detection in the laboratory of strains of microorganisms that are resistant. Such resistance may either be a characteristic associated with the entire species or emerge in strains of a normally susceptible species through mutation or gene transfer. Resistance genes encode various mechanisms which allow microorganisms to resist the inhibitory effects of specific antimicrobials. These mechanisms offer resistance to other antimicrobials of the same class and sometimes to several different antimicrobial classes. All antimicrobial agents have the potential to select drug-resistant subpopulations of micro organisms. With the widespread use of antimicrobials, the prevalence of resistance to each new drug has increased. The prevalence of resistance varies between geographical regions and over time, but sooner or later resistance emerges to every antimicrobial.

While much evidence supports the view that the total consumption of antimicrobials is the critical factor in selecting resistance, the relationship between use and resistance is not a simple correlation. In particular, the relative contribution of mode of use (dose, duration of therapy, route of administration, dosage interval) as opposed to total consumption is poorly understood. Paradoxically, underuse through lack of access, inadequate dosing, poor adherence and sub-standard antimicrobials may play as important a role as overuse.

There is consensus, however, that the inappropriate use of antimicrobial agents does not achieve the desired therapeutic outcomes and is associated with the emergence of resistance. For this reason, improving use is a priority if the emergence and spread of resistance is to be controlled.

Hence, prevention and containment of the spread of AMR through the continuous availability of safe, effective, and quality-assured antimicrobials and their effective use is indispensable. This can only be achieved through the collaborative actions among partners in human health, agriculture, the food industry, teaching and research institutes, civil societies and associations, the pharmaceutical industry, and global stakeholders to synergize efforts and resources.

Adverse Drug Reactions

Adverse drugs reactions (ADRs) are unwanted effects that occur at certain therapeutic doses. They could be mild (where no intervention is required), moderate (where switching to another medicine is necessary), severe (where an antidote should be employed to alleviate the situation), or lethal. They could also be predictable (extensions of pharmacological effects) or unpredictable (bizarre reactions which are not expected in all patients taking the medicine, such as hypersensitivity and idiosyncratic reactions). ADRs are different from toxic reactions for the latter occur at doses higher than therapeutics. They are also different from side effects as this is a broader concept, i.e., including both beneficial and all unwanted effects, which may not necessarily be noxious.

The two extreme age groups, i.e., pediatric and geriatric patients, are more susceptible to ADRs due to physiological and pathological factors. Special precaution should be taken for coexisting illnesses, such as kidney and liver diseases, as they could contribute to ADRs. Pre-marketing clinical trials cannot be exhaustive as far as detection of all ADRs is concerned. Only the most common ADRs could be detected during pre- marketing trials. It is therefore, important to devise methods for quickly detecting ADRs. This could be carried out by post-marketing surveillance, i.e., ADR monitoring. All health professionals have the responsibility to report any ADR observed to FMHACA. See Appendix 12 for Adverse Drug Event reporting form.

Priority Life-Saving Medicines for Women and Children

Priority Life Saving Medicines for Children Under Five

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