Lead Directorate Pharmacist
Royal Infirmary of Edinburgh
In obstetrics and gynaecology, the range of pharmaceutical care issues is similar to other areas of surgery, such as pain management, nausea and vomiting, and infection. In obstetrics, some pharmaceutical care issues are routine and therefore time-consuming due to rapid patient turnover. In addition, recent advances have led to the avoidance of major surgery and use of medical treatments as an alternative or adjunct to surgery. These advances have involved the use of unlicensed medicines and high-risk patients. In view of the range of pharmaceutical care issues and small pharmacy staffing resources, a strategy was developed to deliver a consistent level of clinical pharmacy service in our hospital, through collaboratively produced and implemented guidelines where possible. This strategy has enabled the delivery of individualised care where needed.
These guidelines have been ratified by the Trust Drug and Therapeutics Committee and have incorporated national guidelines and local clinical practice, encouraging ownership and adherence. Some of our guidelines have now been incorporated into integrated care pathways to improve access to carers at the point of prescribing. A few examples are outlined here to demonstrate the range of input by pharmacists within these specialties.
Augmentation of labour
During spontaneous or induced labour, some women may exhibit less than optimal uterine activity (dysfunctional labour) to be able to deliver the baby. Oxytocin by continuous infusion is commonly used to speed up labour,(1) which needs to be differentiated from its occasional use to induce labour.(2) Some units also routinely use oxytocin to shorten labour, referred to as “active management of labour”.(3) This practice has been claimed to reduce the rate of caesarean section;(3) however, this finding has not been validated in a recent trial(4) and has been criticised.(3)
Starting dosages of oxytocin infusion have varied from 0.5–6mU/min, increasing at intervals of 20–60 minutes.(1–4) This wide dosage range is probably due to pooled data from poorly controlled trials. In addition, there is considerable variation in sensitivity of the pregnant uterus to oxytocin. There are advocates of low dose and hence fewer side-effects, compared with high dose, shorter labours and risk of side-effects.(1,2,4) The main concerns are the risk of uterine rupture, haemorrhage and fetal distress. Oxytocin also has an antidiuretic effect. Urinary output can fall and result in water intoxication, which may present as confusion, nausea, convulsions and, rarely, coma.(2,3) Dosage titration is essential.
When it was decided to introduce a high-dosage regimen, the published literature was evaluated to validate the dosage. Owing to the risk of hypotension, rapid bolus dose was not advised, and absorption by the intramuscular route is too erratic. To improve accuracy, small volume infusion by an infusion pump was recommended. To reduce potential hazards of this infusion, documentation (an administration chart) was designed for monitoring the infusion. Advice was provided on a suitably diluted preparation. In addition, continuous monitoring of maternal heart rate, blood pressure and uterine activity, progression of labour and fetal heart rate supported use. There was collaboration in the subsequent audit of this practice.
Antenatal and postnatal routine pharmaceutical care issues
Pain management still remains a challenge in obstetrics and gynaecology. Other common care issues in obstetrics include constipation, heartburn and anaemia. Instead of reacting to these routine problems, the strategy was to produce guidelines similar to those for pain management within a multidisciplinary group. For the past nine years we have used group protocols,(5) which have incorporated our guidelines. These group protocols have recently been superseded by Patient Group Directions (PGDs).(6) The Trust Drug and Therapeutics Committee have ratified these PGDs. Extended-role midwives have used PGDs to manage routine pharmaceutical care issues in the antenatal and postnatal period and sometimes throughout the hospital stay. An inhouse education and training programme and assessment of competency directed by a multidisciplinary group have supported these midwives. Pharmacists have also been involved in the production and audit of PGDs. It was encouraging to find that the use of PGDs by midwives to manage pain had improved the quality of prescribing with respect to optimal use of analgesics, pain management and documentation when compared with prescribing of analgesics by doctors.(7) For major abdominal gynaecological surgery, again a postoperative pain, nausea and vomiting guideline was produced. To encourage adherence, preprinted medicine charts were introduced to reinforce recommendations. This strategy has not only improved pain management(8) but also clarity and accuracy of the prescription.
Management of unruptured ectopic pregnancy by methotrexate (MTX)
Ectopic pregnancy is a common cause of pregnancy-related death. Not all of these pregnancies are harmful; up to 69% can abort spontaneously.(9,10) Open laparotomy was traditionally used to manage ectopic pregnancy. Laparoscopic tubal surgery (LTS) has been shown to be superior – giving less blood loss, less need for analgesics, shorter hospital stay, faster postoperative recovery, better subsequent intrauterine pregnancy rate – and is less costly.
Over the past 15 years in selected women, MTX, a folic acid antagonist and known cytotoxic agent, has been considered a medical alternative to LTS.(9–11) It has all the advantages of LTS and avoids the need for surgery and removal of the fallopian tube; however, it is unlicensed for this purpose. Pharmaceutical care issues that had to be addressed were inclusion and exclusion patient criteria, pretreatment monitoring, dosage, administration, side-effects, drug interactions, post-treatment monitoring, unlicensed status, health and safety to patient and carer, and follow-up in hospital and by the GP. Written information for the patient, which has incorporated advice from the UK Ectopic Pregnancy Support Group, was also produced. An integrated care pathway will be introduced, and an audit of the management of all ectopic pregnancies is planned.
An interesting question raised at a recent EAHP seminar asked, why have local guidelines when national guidelines are available? These national guidelines were out of date and did not have a multidisciplinary input.(10) Essential aspects such as safe handling and administration, and pre- and postmonitoring issues were not addressed. The patient information leaflet has enabled women to make an informed choice.
First-trimester medical termination of pregnancy
In 1995, 45% of our abortions were induced medically; in 2000 this had increased to 60%. Mifepristone 600mg plus a single dose of 1mg gemeprost (a prostaglandin) have been licensed for first-trimester abortions (up to 63 days). Gemeprost has posed many problems. It needs freezer storage conditions, administration was difficult as we used the unlicensed dose of 0.5mg (half a pessary), and it was expensive. These factors led to the use of misoprostol as an alternative for first-trimester terminations.
Misoprostol has no storage problems, is at least 20 times cheaper, of equal efficacy and possibly has a better safety profile, but it is unlicensed for this purpose and is a known teratogen.(12–14) In view of its unlicensed indication, dosage and route for this purpose, an evaluated report was submitted to the Trust Drug and Therapeutics Committee for ratification. A guideline was produced to include advice on patient selection criteria, dosage, administration, contraindications, precautions, side-effects, monitoring issues and follow-up. A patient information leaflet was also produced. An integrated care pathway has been introduced, and preprinted medicine charts have encompassed all aspects of care.
Women’s preferences, plus improvements in treatment and surgical techniques, may have led to some of the advances discussed here. These changes have resulted in shorter hospital stays and avoidance of major surgery. Yet many of the routine care issues still have to be addressed. A strategy to deliver consistent evidence-based care through the use of locally produced and ratified user-friendly guidelines has been found to improve care.(7,8)
Although it is encouraging to find this improvement in care, production and implementation of guidelines are very time-consuming. To be of most benefit, guidelines need to be monitored and updated regularly, and a multidisciplinary collaboration is essential. Recently, whenever possible, some of these guidelines have been incorporated into integrated care pathways. Pharmacists have an important role in the production and implementation of guidelines, with the opportunity also to deliver individualised care where needed.
- ACOG. Int J Gynaecol Obstet 1996;53:73-80.
- NICE. Inherited clinical guideline D. induction of labour. London: NICE; 2001.
- Thornton JG. BMJ 1996;313:378.
- Merril DC, Zlatnik FJ. Obstet Gynecol 1999;94:453-63.
- Crown II Report. Review of prescribing, supply and administration of medicines – final report. London: Department of Health; 1999.
- Scottish Executive Health Department. Patient group directions. NHS HDL. 2001; No7.
- Wright SA, et al. Pharm World Sci 2000;22:B16.
- Gynaecology Clinical Improvement Programme Team. Pain, nausea and vomiting management in major gynaecological surgery. Roche Clinical Improvement Team Award; June 2001.
- Tay JI, et al. BMJ 2000;320:916-9.
- RCOG. The management of tubal pregnancies. London: RCOG; 1999.
- Lipscomb GH, et al. N Engl J Med 2000;343:1325-9.
- RCOG. The care of women requesting induced abortion. Guideline 7. London: RCOG; Review date 2003.
- Goldberg AB, et al. N Engl J Med 2001;344:38-47.
- Newhall EP, Winikoff B. Am J Obstet Gynecol 2000;183(2):544-53.
Royal College of Obstetricians and Gynaecologists (RCOG)
For full versions of Guidelines in Obstetrics and Gynaecology contact:
The Clinical Effectiveness Support Unit
or visit their website W:www.rcog.org.uk
National Institute of Clinical Excellence (UK)
Courses (symposia) providing updates for UK pharmacists and medical staff are available from: Faculty of Medicine
Division of Paediatrics, Obstetrics and Gynaecology
F:+44 (0)20 75942155