In January 2007, Mrs B, a 33-year-old woman, was seen three weeks after the birth of her second child and was prescribed six months of the progesterone only pill (POP). She was breastfeeding at this stage. She had attended the surgery earlier that month with phlebitis but it was noted that the varicose veins were “clear” at the time of prescribing.
In July 2007 the practice nurse prescribed a further six months of the POP without face-to-face consultation, and a further one month’s supply was issued in December 2007. In January 2008 Mrs B presented with stress incontinence, for which a referral to urology was made. At this consultation it was noted that there were “no problems with the POP and the BP was normal”. Six months of the POP was issued.
In May 2008 Mrs B consulted about mild acne and asked if co-cyprindiol could be prescribed. The GP noted that Mrs B’s father had previously suffered a DVT and advised against it. In July 2008 the practice nurse supplied a further six months of the POP.
In October 2008 Mrs B presented to the practice with an unplanned pregnancy and she was referred to the antenatal clinic.
A review of the records revealed that Mrs B had been registered with the practice since 1999. She had been on the combined oral contraceptive (COCP) since 1992, which she had stopped in 2000 when she began trying for a family. At her new patient medical in 1999 it was noted that she was a non-smoker, and there was no family history of diabetes or heart disease.
The original consultation, when she was prescribed the POP, was in October 2003 after the birth of her first child. The notes read: “16 days post-natal. Wants contraception. Discussed and start Noriday.”
Over the next four years there were a dozen clinical encounters. Three of these were pill checks with the practice nurse. A typical entry read: “On Noriday. Happy with it. No missed pills, occasional headaches [BP normal].”
There were also five occasions when the POP was issued without face-to-face consultations and four encounters for unrelated issues.
Mrs B’s legal team alleged that she should have been advised to change from a POP to a COCP when she finished breastfeeding her second child in 2007 and this would have helped to prevent her unwanted pregnancy in 2008.
Expert opinion was that when prescribing contraception there is a duty to discuss contraceptive choices with a patient – specifically about the pros and cons of a COCP and a POP in this case. The discussion should cover failure rates, the method of taking the pill, common side effects (including effects on menstruation) and the risk of thrombosis. This would allow the patient to reach an informed decision. The expert felt that part of this could have been achieved by advising the patient to read the product information in the packet insert.
In this case the expert felt that it was reasonable not to prescribe the COCP due to the family history of DVT (and also the relative contraindication of the varicose veins). A defence denying liability was served by MPS – three months later Mrs B discontinued her claim and MPS recovered all costs.
- It is striking that despite so many clinical encounters over many years and her own prolonged use, Mrs B still alleged that she was unaware of key issues with the POP and COCP, including the three-hour window in which to take the POP. It is a timely reminder that giving information is important, but checking that the patient has understood the information is vital. This forms the basis of valid consent to treatment. In this case it would have been all too easy to view the ‘pill check’ as a routine encounter, make assumptions and be less rigorous in documentation.
- A number of the prescriptions were issued by the practice nurse or as repeats by the administration team in the practice. When devolving responsibility it is important to ensure that there is a clear practice policy on what is expected of staff and that this protocol is thought through, written down and being adhered to.
- Continuing professional development: Newer guidance on contraception UKMEC (UK medicines eligibility criteria) 2009 updates earlier guidance on varicose veins (no contraindication to the COCP), family history of DVT (contraindication if age <45 in the family member) and on contraceptive options when breastfeeding and is a timely reminder of the constant challenge of keeping our knowledge up to date: www.fsrh.org/pdfs/UKMEC2009.pdf