Responses to recent member enquires – record keeping about vaping/e-cigarette use & discontinuation of spermicide in the UK

Our Clinical Effectiveness Unit (CEU) provides an enquiry service for FSRH members. Our responses summarise the available evidence and guidance in relation to use of contraception by a woman with a particular medical condition. Clinicians should use the evidence identified to inform their own clinical decision-making. Where appropriate, questions relating to service delivery and quality are directed to the Clinical Standards Committee for a response.

Current FSRH members can log in to MyFSRH to view existing requests and answers and submit new evidence requests as part of their membership benefits. After logging in, click on 'Members evidence request' under 'My Member Benefits' to see the full database of questions and answers. You can search the database by entering a word, sentence or phrase. 

Below are 2 recent enquiries that may be of interest to members. 

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Question 1

Following discontinuation of nonoxinol-9 (Gygel) vaginal spermicidal cream, we are currently looking for an alternative product to be used with Caya diaphragms. Are you able to advise on an alternative? 

Response from the Clinical Effectiveness Unit: 

Diaphragm users should be advised to use a spermicide in conjunction with the diaphragm.[1,2,3]  

The only alternative to nonoxinol-9 that the CEU is aware of is Contragel® [3] (also known as Caya® [4]). These preparations do not contain nonoxinol-9 but instead contain lactic acid, which decreases the vaginal pH, making it inhospitable to sperm.[3,4]  A 2020 systematic review of RCTs [5] found that pregnancy rates were high (8-15% during 6 months of follow up) with female barrier contraceptives (including the newer devices like Caya). The review concluded that nonoxynol-9 and acid-buffering gel did not differ significantly from one another in terms of effect on pregnancy rate, but that acid-buffering gel was better tolerated, with better continuation rates.   

Contragel and Cayagel are not licensed in the UK as they are not medicines. They therefore cannot be prescribed. They are class II medical devices [3] and are available for users to buy over the counter or online.   

Services that wish to supply Contragel or Caya gel could seek advice from their local pharmacies and non-medicinal stock procurement teams as to whether or not it is possible to order in these products for patient use.  

References 

1. Faculty of Sexual & Reproductive Healthcare. Barrier Methods for Contraception and STI Prevention. August 2012, amended October 2015. Available online: https://www.fsrh.org/standards-and-guidance/documents/ceuguidancebarriermethodscontraceptionsdi/ (accessed 27/07/2023)  
2. Faculty of Sexual & Reproductive Healthcare. FSRH New Product Review: One size contraceptive diaphragm (Caya®). August 2014. Available online: https://www.fsrh.org/standards-and-guidance/documents/cec-ceu-newproductreview-caya-aug-2014/ (accessed 27/07/2023) 
3. The Valley Initiative Ltd. Contragel®. Available online: https://contragel.co.uk/ (accessed 27/07/2023)  
4. The Valley Initiative Ltd. Caya® Contoured diaphragm. Available online: https://caya.co.uk/caya-gel.html (accessed 27/07/2023)  
5. Lindh I, Othman J, Hansson M, Ekelund AC, Svanberg T, Strandell A. New types of diaphragms and cervical caps versus older types of diaphragms and different gels for contraception: a systematic review. BMJ Sexual & Reproductive Health. 2021 Jul1;47(3):e12.  

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Question 2 

Vaping is very common now. There is no consensus about whether we should be asking or documenting use of e-cigarettes, and no guidance on how to view any health risk that it poses. I have seen the previous enquiries saying that data are inadequate, and that the FSRH CEU cannot make any evidence-based recommendation as to how use of e-cigarettes affects cardiovascular risk in CHC users; however increased risk of arterial thrombotic events cannot be excluded, and that recommendations for vape users should currently be the same as for smokers. I have also seen articles that say that there is increased VTE risk or increased platelet adhesion and endothelial dysfunction.

Should we be documenting vaping in addition to asking about smoking? Even Never Smokers now admit to vaping. This is further complicated by the availability of nicotine-containing and non-nicotine vapes. 

Is there any update on this subject please? 

Response from the Clinical Standards Committee: 

The FSRH do not have any standards that cover the use of vaping or the associated risks due to the lack of evidence at this stage.  In the absence of clear and robust data specifically associated to the risk of vaping to health, it would be prudent and best practice to capture information of those vaping and clearly document. At this stage given increased risk of arterial thrombotic events cannot be excluded those vaping should be risk assessed the same as those smoking’ 

The MHRA have issued guidance regarding history-taking, e-cigarette use and vaping as part of Drug Safety Update which was published in 2020. This highlights the risks around e-cigarette use or vaping and lung injury.[1] It advises the following: 

Routinely document e-cigarette history

As part of routine clinical practice, clinicians are advised to document use of e-cigarettes or vaping devices in medical records for all patients as they would with smoking. Clinicians should routinely document: 

• Name or brand of product used 
• Type of product (if known) 
• Duration and frequency used 
• Substances vaped (for example, nicotine or recreational substances) 
• Strengths of substances

Reference 

1.  Medicines and Healthcare products Regulatory Agency. GOV.UK. E-cigarette use or vaping@ reporting suspected reactions, including lung injury. Published 27 January 2020. Available online: https://www.gov.uk/drug-safety-update/e-cigarette-use-or-vaping-reporting-suspected-adverse-reactions-including-lung-injury (accessed 27/07/2023)