Obstetrics

Why is obstetric pharmaceutical care important? (1)

Women of childbearing age need their chronic conditions managed during pregnancy. Are the drugs safe in pregnancy? Toxic effect on developing foetus? Physiological changes during pregnancy, can affect PK of drugs, doses used outside of pregnancy

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Why is obstetric pharmaceutical care important? (2)

Thalidomide – previously used for morning sickness but there were reports of severe limb defects and other organ dysgenesis. Highlighted how medication use can impact on the developing foetus. Need systems in place to check

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What is teratogenesis?

Defined as the dysgenesis of fetal organs as evidenced either structurally or functionally (e.g.brain function). Can include restricted growth or death of the foetus, carcinogenesis and malformations. Few drugs have been tested formally during pregnancy (

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Give examples of known teratogens

Carbamazepine (neural tube defects). Phenytoin (growth retardation, CNS deficits). Warfarin (skeletal and CNS defects, Dandy-Walker syndrome). Drugs used for many years are teratogenic (don’t have information on new agents). Information about known terato

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Describe features of congenital malformations (1)

The background incidence in the population is between 2-3%, with 75% of unknown aetiology. Exposure to a drug during the pre-embryonic phase, which lasts until the 17th day after conception will either result in survival of the intact embryo or death (all

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Describe features of congenital malformations (2)

During the foetal period, from day 56 to birth, organs such as the cerebral cortex and renal glomeruli continue to develop and are susceptible to damage. Teratogenicity is usually dose-dependent, e.g. sodium valporate and neural tube defects. (embryonic d

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Describe drug testing in rodents

Although rodents are normally used to evaluate the safety of drugs in pregnancy, their physiology, metabolism and development are very different to humans. It cannot be assumed that a drug that does not cause embryotoxicity, foetotoxicity or teratogenicit

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Describe features of the placenta

Nutrition, excretion, immunity, endocrine function. Crossing the placenta – most drugs will cross by simple diffusion. Non-ionised, lipid soluble drugs preferenced over polar, ionised, hydrophilic compounds. High MW don't cross (but toxicity via vasoconst

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How can the risks with drug use be reduced during pregnancy?

Consider non-drug treatment, consider period of gestation and avoid in first trimester, avoid known teratogens, use the lowest effective dose

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Where can you look for information about safety?

SPC, drug company, SPS, UKTIS, Briggs

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What are the physiological changes of pregnancy that affect PK of drugs?

Growing baby affects position of organs/function. Organs need to provide nutrients to baby. Normally physiological function will change in pregnancy. RR increases in the 1st trimester. CO/total volume increases. Increased GFR, altered enzymes

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What are the predicted PK changes?

Absorption (CO and blood flow to skin increases). Distribution (plasma volume and total body water increases). Metabolism (hepatic and extra hepatic metabolism altered). Excretion (renal blood flow and GFR increases)

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Which conditions involve the continuation of drug therapy?

Diabetes, HIV, HTN, asthma, DVT/PE, transplant patients, epilepsy etc

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What are the benefits of breastfeeding?

Less chance of: diarrhoea, vomiting, infections, constipation, obesity (reduce risk of TIIDM), eczema. Benefits for mother: reduce risk of breast/ovarian cancer, naturally burns up to 500 calories per day. Strong bond built between mother and baby. Money

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Which drugs are safer to prescribe to a breastfeeding mother?

Highly protein-bound, shorter half-life, prescribed for neonates and children, low plasma: milk ratio (lower ratio, less that reaches milk)

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What factors need to be considered?

The mother's need for the drug. Age and maturity of baby (i.e. are the liver and
kidney systems fully functioning). The volume of breast milk being taken. Safety information about the drug

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What is the link between clearance and age?

As age increases, the percentage of clearance increases. Case example codeine (pharmacogenetics of morphine poisoning in a breastfed neonate)

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State features of drug transfer into breast milk

Low plasma protein binding, low molecular weight, high lipophilicity and cationic drugs favour increased excretion of the drug into milk. Biochemical characteristics of milk, including a higher pH and higher lipid contents, compared to the plasma

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What is the mechanism of drug transfer?

Mostly by passive diffusion – although drug transporters are increasingly recognised as playing a role

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Which factors affect the diffusion of a drug into milk?

Maternal PK. Physiological composition of blood vs milk. Characteristics of drug

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Give examples of drugs which high infant exposure

Amiodarone, carbimazole, isoniazid, lithium, metronidazole, phenobarbitone, theophylline, propylthiouracil (known problems - table)

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What is the milk-plasma ratio?

Ratio between drug concentration in milk and the maternal plasma is called the milk to plasma drug concentration ratio (MP ratio). Lower ratio (less drug in milk

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How do you calculate the exposure index?

100 x MP ratio x A / infant drug clearance (where A is the milk intake and Cl is expressed as ml/kg/min)

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What are the drugs of choice for breastfeeding mothers?

Analgesics (paracetamol, ibuprofen, morphine), anticoagulants (warfarin, heparin), antidepressants, antiepileptics, antimicrobials, labetalol, propranolol, prednisolone (table)

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Where can you look for information about safety?

UKDILAS, LactMed

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Describe features of DOACs in breastmilk

DOACs in breastmilk - 4 healthy subjects, 6 months post-delivery, in the phase of moving baby from breastmilk to solid/formula. Key findings for single doses – maternal plasma concentration of rivaroxaban (similar to normal healthy adult), drug does distr

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Which factors influence embryonic development and foetal growth?

Nutrition (folic acid), infection (rubella), toxins (nicotine, alcohol, opiates, occupational exposure), medicines (POM, OTC, misuse), genetic factors (CF, sickle cell disease, genetic screening), paternal exposure to toxins and medicines

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What is the effect of pregnancy on drugs (ADME)?

Absorption (decreased gastric/intestinal motility, reduced gastric acid secretion, increased gastric pH, nausea, vomiting, hyperemesis gravidarum). Distribution (changes in total body weight and body fat, increase EC fluid and total body water, altered me

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What is shared care?

Primary health care doctors, midwives, obstetricians. Specialist joint clinics with multidisciplinary teams – examples include diabetes, epilepsy, renal, cardiac, HIV. Obstetric medicine specialty. Pharmacists – Women’s Health specialty - UKCPA. OTCs

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State features of medicines optimization in pregnancy (1)

Understanding the patient’s experience: Pharmacokinetics alter in pregnancy BUT the effect of medicines is also altered by: Poor medicines adherence, Fear of harming fetus, Always discuss the benefits and risks of treatment, and the consequences of stoppi

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State features of medicines optimization in pregnancy (2)

Pre-pregnancy counselling should be essential for all women receiving long-term treatment with medicines (but there is a lack of funding). PK altered in pregnancy but the effect of medicines is also altered by poor medicine adherence (e.g. metformin, valp

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What is the role of the pharmacist in optimizing maternal health?

Maternal and child nutrition (vitamin D). Obesity. Reducing smoking (NRT). Immunization services. Teenage health.

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What are the consequences of obesity?

Don't know impact of drugs in BMI >40. Higher rates of congenital abnormalities (high dose of folic acid supplementation pre-pregnancy and during first trimester, 5 mg OD). Increased risk of -pre-eclampsia (aspirin 75 mg OD throughout pregnancy). Gestatio

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Describe features of vitamin D deficiency

Reduces: risk of pre-eclampsia and gestational diabetes, risk of low-birthweight baby, risk of severe bleeding after birth. Babies born with vitamin D deficiency may have: neonatal tetany (hypocalcaemic seizures), impaired growth, rickets

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What is the trend for mothers' age at birth of baby in England and Wales?

Mothers becoming older. More women in their 40s getting pregnant

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State features of maternal deaths

Maternal deaths 9.2 per 100,000 women (2015-17) up to six weeks after giving birth or the end of pregnancy. More than two-thirds of women who died had pre-existing mental or physical health issues. 58% died from “indirect” causes (eg non-genital infection

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State features of perinatal mental health

Perinatal mental health refers to a woman’s mental health during pregnancy and the first year after birth. Psychiatric illness is one of the leading causes of maternal deaths in the UK and Ireland – 31% of maternal deaths between 6 weeks and 1 year post-p

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What are the risks of medications to treat severe mental illness?

Major malformation (first-trimester exposure). Miscarriage (spontaneous abortion). Neonatal toxicity and withdrawal effects (third-trimester exposure). Long-term neurobehavioural effects and growth impairment.

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What are the potential benefits of treating severe mental illness for mother and baby?

Reducing harm to the mother – poor self-care, self harm, impulsive acts, poor judgement, substance misuse. Reducing harm to the fetus or neonate (eg prematurity and low birth weight; neglect or infanticide)

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What are the factors to consider when prescribing psychotropic medicines in pregnancy?

Unlicensed for use in pregnancy/breastfeeding. Document consent. Psychological interventions before starting medication. Choose the drug with the lowest risk profile for the woman, fetus and baby. Use the lowest effective dose. Use monotherapy, dose adjus

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Describe features of epilepsy in pregnancy

Optimise seizure control before pregnancy (pre-conceptual counselling). Folic acid 5mg daily – pre-pregnancy and first trimester. Use epilepsy monotherapy whenever possible. Risks of malformations and possible neurodevelopmental impairment with higher dos

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What are the actions for pharmacists regarding the use of sodium valproate in women of child-bearing potential?

Ensure the Patient Card is provided every time valproate is dispensed. Remind patients of the risks in pregnancy and the need for highly effective contraception. Remind patients of the need for annual specialist review. Ensure the patient has received Pat

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Describe features of pregnancy prevention programmes

Oral retinoid medicines acitretin, alitretinoin, and isotretinoin. Topical retinoids (adapalene, alitretinoin, isotretinoin, tazarotene, and tretinoin) – no PPP but risk cannot be excluded . Oral tretinoin, oral bexarotene. Thalidomide analogues. Mycophen

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Describe the risks of diabetes in pregnancy

Up to 5% of pregnancies involve women with diabetes (England & Wales) of which approx. 7.5% are Type 1, 5% are Type 2 and 87.5% are Gestational diabetics (GDM). Pre-existing diabetes – Type 1 or Type 2. Risks for mother (miscarriage, pre-eclampsia), risks

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What are the treatments and monitoring requirements for diabetes in pregnancy? (1)

Intensive monitoring and frequent dose adjustments to maintain tight glucose control – including pre-pregnancy. Insulin – isophane is long-acting insulin of choice. Detemir (Levemir) or glargine (Lantus) – if good control, consider continuing in pregnancy

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What are the treatments and monitoring requirements for diabetes in pregnancy? (2)

Gestational Diabetes (GDM).
Mothers – increased risk of developing Type 2 diabetes. Treatments: Diet and exercise, Insulin Metformin, Glibenclamide – if blood glucose targets not achieved, insulin declined or metformin not tolerated

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How are pregnant women managed for hypertension and coronary heart disease?

Aspirin – given for prevention of pre-eclampsia (hypertension + proteinuria, in pregnancy). Statins – avoid. Angiotensin-converting enzyme inhibitors – avoid, First trimester - increased risk of congenital cardiac or CNS malformations? 2nd/3rd trimester -

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How is pre-eclampsia managed in pregnancy?

Pregnancy-related disease. Diagnosis: HTN and proteinuria, PCR, 24 h urine collection. Treatment: labetalol (licensed), nifedipine, methyldopa, hydralazine (severe HTN, IV), magnesium sulphate (reduced risk of fits)

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Whare are the guidelines for postnatal treatment of hypertension (+/- pre-eclampsia)? (1)

Offer enalapril to treat hypertension in women during the postnatal period, with appropriate monitoring of maternal renal function and maternal serum potassium.

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Whare are the guidelines for postnatal treatment of hypertension (+/- pre-eclampsia)? (2)

For women with hypertension in the postnatal period, if blood pressure is not controlled with a single medicine, consider a combination of nifedipine (or amlodipine) and enalapril. If this combination is not tolerated or is ineffective, consider a beta-bl

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Whare are the guidelines for postnatal treatment of hypertension (+/- pre-eclampsia)? (3)

When treating women with antihypertensive medication during the postnatal period, use OD medicines when possible. Where possible, avoid using diuretics or angiotensin receptor blockers to treat hypertension in women in the postnatal period

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Describe features of anticoagulation in pregnancy

Warfarin teratogenicity– exposure between weeks 6-9 causes defective bone ossification. 2nd and 3rd trimester exposure may cause eg CNS abnormalities (? because microhaemorrhages in the brain). Low Molecular Weight Heparins – acceptable for use. DOACs - N

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What are the recommendations for VTE thromboprophylaxis in pregnancy?

Assessment of risk factors. Use LMWH for
thromboprophylaxis. Score 3 or more antenatally – consider LMWH. Score 2 or more postnatally - give LMWH.

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What are the recommendations for HIV treatment in pregnancy?

Mother to Child Transmission (MTCT) No intervention 30-35%. No breastfeeding 15-20%
+ Zidovudine (AZT) therapy 7.6%
(ACTG 076 protocol (1994)) + Elective Caesarean Section (ELCS) <5%. Antiretroviral therapy – HAART, cART or START

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What are the risk factors for HIV transmission?

Risk factors for transmission. Viraemia. Mode of delivery. Duration of membrane rupture. Delivery < 32/40. Breast feeding – see BHIVA guideline

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What is baby posture exposure prophylaxis?

Zidovudine 4mg/kg body weight orally BD for two to four weeks. Nevirapine +/- lamivudine (or alternatives if eg resistance)

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What are the recommendations for the prevention of influenza in pregnancy?

Inactivated seasonal influenza vaccine considered safe in pregnancy. Antigenic drift / antigenic shift – vaccine reformulated each year. Recommended in pregnancy in UK for each flu season since 2010/11.

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What are the recommendations for the treatment of influenza in pregnancy? (1)

Simple treatments – antipyretics (paracetamol); hydration. Oseltamivir (“Tamiflu”), Prodrug - Predominantly hepatic metabolism to active drug
Eliminated mainly via kidneys – possibility of interactions, Side effects – nausea and vomiting

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What are the recommendations for the treatment of influenza in pregnancy? (2)

Zanamivir (“Relenza”)
Oral bioavailablity low (1-5%)
Low systemic exposure from inhaled dose (10-20%), Not metabolised; Excreted unchanged via kidneys, Inhaled powder – diskhaler - Contains lactose - May cause bronchospasm

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What are the complications of COVID-19 in pregnancy?

Hypercoagulation, thrombi, emboli, pneumonia, respiratory distress syndrome, concerns about breast milk transmission, cardiac strain, endothelial dysfunction, altered cell immune response, placental infiltration, increased anxiety and stress, vertical tra

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Describe the latest pregnancy data for COVID-19 (1)

Pregnant and recently pregnant women with covid-19 diagnosed in hospital are less likely to have or manifest symptoms of fever, dyspnoea, and myalgia than non-pregnant women of reproductive age. Increased risk of being admitted to ICU

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Describe the latest pregnancy data for COVID-19 (2)

Risk factors: increasing maternal age, high body mass index, non-white ethnicity, pre-existing comorbidities, and pregnancy-specific disorders such as gestational diabetes and pre-eclampsia. Pregnant women with covid experience pre-term birth

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Describe the latest pregnancy data for COVID-19 (3)

Vertical transmission from mother to fetus possible but rare (3.2% on neonatal nasopharyngeal swab). Viral RNA has been detected occasionally in breastmilk but it is unclear if this is viable and infective virus. Covid-19 antibodies found in breast milk

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Describe features of COVID-19 vaccination

Who can be vaccinated in pregnancy? Those with high risk medical conditions who have a greater risk of severe illness from COVID-19 (“clinically extremely vulnerable”). Health or social care workers – who are at very high risk of catching COVID-19

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Describe features of COVID-19 treatment

Pregnant women can be recruited for the Recovery trial. Pragmatic, randomised trial, recruited to synthetic neutralising antibodies, aspirin and/or tocilizumab arms – or usual care. Prednisolone PO 40mg OD or hydrocortisone 80 mg IV BD (avoid dexamethason

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Which medication is used for the medical treatment of ectopic pregnancy?

Methotrexate

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Which medications are used for the medical termination of pregnancy

Mifepristone (yellow, cylindrical 200mg tablets), Anti-progesterone, Misoprostol (white, hexagonal 200 microgram tablets), Prostaglandin E1 analogue

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Where can you find information about medication safety in pregnancy?

SPC, drug company, SPS, UKTIS, local medicines information centres

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What are the FDA categories?

A: No risk shown. B: No risk shown in animal studies but no controlled studies in pregnant women OR some fetal risk in animal studies but no risk shown in human studies. C: Some risk shown in animal studies but no human studies. D: some risk. X: foetal h

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What is the WHO guidance for breastfeeding?

As a global public health recommendation, infants should be exclusively breastfed for the first six months of life to achieve optimal growth, development and health

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What are the benefits of breastfeeding for babies?

E.g. transferral of antibodies, protection from infection, reduction of risk of allergies or diabetes, slower, healthier weight gain reducing chance of later obesity, less colic, constipation, diarrhoea

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What are the benefits of breastfeeding for mothers?

Reduced risk of osteoporosis, ovarian or breast cancer, weight loss

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Describe features of breastmilk and PK considerations (1)

Half-life T1/2 - Shorter (1-3 hours) preferable to longer (12-24 hours) for breastfeeding (drug levels falling by the time of next feed) but longer T1/2 preferable for adherence. Milk to plasma ratio M/P - Concentration of drug in mother’s milk/ concentra

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Describe features of breastmilk and PK considerations (2)

Tmax - (Cmax). Plasma binding PB- High plasma binding (>90%) preferable, Drug stays in plasma compartment. High MW (lower transfer of milk). Oral bioavailability. High Vd (produce low milk levels. Acid dissociation constant (ionic drugs less likely to cro

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Which factors need to be considered when prescribing medicines during breastfeeding? (1)

Baby - What is the potential risk to the baby? Is the drug licensed in children? What gestation was the baby at birth? How old is the baby now? How often is the baby feeding from the breast?

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Which factors need to be considered when prescribing medicines during breastfeeding? (2)

Mother - Is the medicine essential for the mother?
Was she taking it during pregnancy?
Chronic or acute use? What are her thoughts?

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Which factors need to be considered when prescribing medicines during breastfeeding? (3)

Drug - licensed for breastfeeding? Pharmacology and PK, S/E and C/I

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What are the psychosocial aspects and breastfeeding?

Fears of poisoning baby when taking drug and breastfeeding. Worries about using formula and not breastmilk. Depression. Breastfeeding problems

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Give examples of postnatal medicines

Essential for mother? Analgesia - codeine. Antibiotics (to treat or prevent infection) – metronidazole (taste). Antihypertensives – betablockers; ACE inhibitors. Iron (for anaemia). Laxatives. Thromboprophylaxis – Warfarin, LMWH (acceptable), DOACs (no in

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Describe features of codeine

Codeine restricted for use as an analgesic in children, or in breastfeeding women. Potentially fatal respiratory depression. Alternatives?
Morphine / Dihydrocodeine / Tramadol / Oxycodone. Avoid codeine/oxycodone and tramadol - CYP2D6 metabolism.

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Describe features of beta blockers

Atenolol - water-soluble, low protein binding, renally excreted; half-life 6-7 hours – excessive betablockade? - high risk in breast-feeding

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Describe features of ACE inhibitors

LACTMED: Because of the low levels of enalapril in breastmilk, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. Briggs – ACE Inhibitors “probably compatible”

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What is the guidance for hypertension during breastfeeding?

Advise women with HTN who wish to breastfeed that treatment can be adapted to accommodate breastfeeding, and the need to take antihypertensive medication doesn't prevent them from breastfeeding. Monitor BP of babies, poor feeding, cold peripheries etc. Av

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Describe features of epilepsy manage during breast-feeding

Lamotrigine. Monitor serum concentrations. Slow neonatal elimination possible (glucuronidation). Sedation, rash. Maternal dose of up to 200mg daily probably safe. Avoid abrupt withdrawal – is “no drug” always “no harm”? Carbamazepine, levetiracetam, pheny

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What is the guidance for diabetes management during breastfeeding?

Pre-existing diabetes – reduce insulin doses immediately after birth and monitor blood glucose levels to establish appropriate dose. Increased risk of hypoglycaemia – especially when breastfeeding – have a meal or snacks available before or during feeds.

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What is the guidance for the management of HTN and CHD during breastfeeding? (1)

Statins – Atorvastatin, fluvastatin, rosuvastatin, and simvastatin - no information available. Manufacturers advice is to avoid breastfeeding. The manufacturers of pravastatin advise against use in breast-feeding mothers as a small amount of drug is prese

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What is the guidance for the management of HTN and CHD during breastfeeding? (2)

Aspirin – “Breast-feeding avoid—possible risk of Reye's syndrome; regular use of high doses could impair platelet function and produce hypoprothrombinaemia in infant if neonatal vitamin K stores low”

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What is the evidence for tacrolimus levels in breast milk?

Results: All infants with serial sampling had a decline in tacrolimus level (approx. 15% per day).
Levels in breast-fed infants not higher than those in bottle-fed infants. Maximum estimated absorption from breast milk is 0.23% of maternal dose (weight-ad

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What is the evidence for azathioprine levels in breast milk? (1)

Widely used as an immunosuppressant. Concern - cytotoxic properties. Metabolised to 6-mercaptopurine (6-MP) then to active metabolites. Various studies – over 50 breastfed infants -
6-MP and active metabolite levels in milk, infant’s and mother’s serum. G

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What is the evidence for azathioprine levels in breast milk? (2)

Present in milk in low concentration; no evidence of harm in small studies – use if potential benefit outweighs risk

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Which medicines are used to stimulate breastmilk production?

Domperidone – 10mg TDS, 7 days and review Metoclopramide – 10mg TDS, 7 days and review
(but there are cardiac risks)

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Which medicines are used to suppress lactation? (1)

Although bromocriptine and cabergoline are licensed to suppress lactation, they are not recommended for routine suppression (or for the relief of symptoms of postpartum pain and engorgement) that can be adequately treated with simple analgesics and breast

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Which medicines are used to suppress lactation? (2)

Cabergoline during first day postpartum, 1 mg as a single dose, suppression of established lactation 250 micrograms every 12 hours for 2 days

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What are the lactation risk categories? (1)

L1 Compatible:
Drug which has been taken by a large number of breastfeeding mothers without any observed increase in adverse effects in the infant.

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What are the lactation risk categories? (2)

L2 Probably compatible:
Drug which has been studied in a limited number of breastfeeding women without an increase in adverse effects in the infant. And/or, the evidence of a demonstrated risk which is likely to follow use of this medication in a breastfe

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What are the lactation risk categories? (3)

L3 Probably compatible:
There are no controlled studies in breastfeeding women, however the risk of untoward effects to a breastfed infant is possible; or, controlled studies show only minimal non-threatening adverse effects. Drugs given only if benefit

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What are the lactation risk categories? (4)

L4 Potentially Hazardous:
There is positive evidence of risk to a breastfed infant or to breastmilk production, but the benefits from use in breastfeeding mothers may be acceptable despite the risk to the infant.

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What are the lactation risk categories? (5)

L5 Hazardous:
Studies in breastfeeding mothers have demonstrated that there is significant and documented risk to the infant based on human experience, or it is a medication that has a high risk of causing significant damage to an infant.

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What are the Briggs and Freeman categories for drugs in pregnancy and lactation?

Compatible, hold breastfeeding, no human data (probably compatible), no human data (potential toxicity), no human data (potential toxicity to mother), contraindicated

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Obstetrics

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