NSW Government-Sponsored Clinical Trial: Extended supply of Oral Contraceptive Pills (OCPs) by Community Pharmacists

The overall aim of this 12-month study is to evaluate the clinical and economic impact and implementation of a service model (intervention) delivered by community pharmacists in NSW and 15 pharmacies in ACT, re-supplying specific oral contraceptive (OCP). Women must be aged between 18 to 35 years (inclusive), taking the pill for contraception purposes only, and has seen their GP/nurse practitioner for a review of their low-risk OCP in the last two years. Pharmacist training; Prior to service delivery, pharmacists will be prepared through an approximately 6 hour online training program (either through the Australasian College of Pharmacy (ACP) or Pharmaceutical Society of Australia (PSA)). Study specific research training modules will also be completed to ensure efficiency in the consultation process, patient consent, recruitment of patients and quality data collection. The PSA training module covers "Fundamentals of contraception" and "Continuation of Oral Contraception by Community Pharmacists- NSW Focus" with the following objectives: • "Discuss the physiology of reproductive hormones and how contraceptive medicines work to achieve contraception. • Compare the different types of contraceptive methods available in Australia. • Recommend appropriate contraceptive method(s) based on individual needs, preferences and tailored medical history assessment. • Compare the efficacy of different contraceptive methods to inform decision-making in clinical practice. • Identify opportunities for pharmacists to engage in opportunistic screening initiatives for cervical cancer, breast cancer and sexually transmitted infections. • Discuss the NSW Oral Contraceptive Trial Clinical Management Protocol for Combined Oral Contraception that pharmacists can use to assist people taking oral contraception." The PSA course "is designed to provide pharmacists with in-depth knowledge and practical skills related to contraceptive counselling and clinical decision-making. The ACP training module covers the following learning objectives: • "Describe the scope of practice of a pharmacist in the management of hormonal contraceptives within professional and legislative frameworks. • Apply knowledge of the female reproductive system to the use of hormonal contraceptives for the prevention of pregnancy. • Demonstrate ability to take a reproductive and general history to identify risk for hormonal contraception and select and resupply eligible contraceptive for your patient requiring contraception. • Apply an approved clinical pathway to the management of hormonal contraceptives in conjunction with a patient, including documentation, follow-up and referral pathways." The University developed modules are intended to cover NSW legislative specific content, the clinical management protocol and research requirements. This training is delivered online through short videos and may take up to 4 hours depending on progress. • Recognise the key requirements for pharmacies who are authorised to deliver the OC service • Recognise the restricted substances in the Authority and the requirements for supply • Recognise the requirements for patient participation in the trial including eConsent • Outline the components of the OC clinical management protocol • Outline criteria for determining if a women is pregnant • Describe key considerations for ensuring patient safety in women taking oral contraceptive pills. Once pharmacists have confirmed their completion of these mandatory training during the consenting process, they will be an ‘approved pharmacist’ which under the NSW Health Authority certifies them to provide the consultation service. Pharmacy consultation The pharmacist will undertake a structured consultation, anticipated to take 10 minutes, with the patient in the community pharmacy guided by an IT program applying a co-designed clinical management protocol. The structured consultation is summarised as follows: • Participant eligibility assessment • Service offering, during which the pharmacist will explain the features of the study • Electronic provision of the Patient information sheet and informed consent form. • During the clinical assessment of the patient, the pharmacist will elicit relevant clinical information, including medical conditions, medication history. Further information may be obtained from the patients’ Electronic Health Record (EHR). • Blood Pressure and BMI will be documented at the initial patient consultation. • Non-pharmacological management may include: (i) Referral to see their medical practitioner, Family Planning or Sexual Health. (ii) Counselling on the importance of getting regular cervical screening tests, breast checks, and STI testing done. (iii) Counselling on the OCP supplied, i.e., o How to take the OCP; What side effects to expect; How to manage adverse effects ; When the OCP is less effective; What to do in event of a missed pill. (iv) Provision of a Consumer Medicines Information sheet. (vi) Provision of advice and referral, of there is a concern that the patient may be at risk for or could have contracted a sexually transmitted disease through unprotected sex, an/ or if the patient indicates that she has been sexually assaulted. • The pharmacist will share a record of the supply with the patient’s usual treating medical practitioner (via fax, secure messaging software, provision of a letter to the patient, or any other approved secure means by NSW Health), where the patient has one, following consent • The pharmacist must keep a clinical record for 7 years that contains: • sufficient information to identify the patient; • date of the treatment; • the name of the pharmacist who undertook the consultation; • any information known to the pharmacist that is relevant to the patient’s diagnosis or treatment (for example, information concerning the patient’s medical history); • any clinical opinion reached by the pharmacist; • actions taken by the pharmacist; • particulars of any medication supplied for the patient (such as form, strength and amount); • notes as to information or advice given to the patient in relation to any treatment proposed by the pharmacist who is treating the patient; • any consent given by a patient to the treatment proposed. • Any medications will be dispensed via pharmacy dispensing software and labelled according to the legislative requirements outlined in the Poisons and Therapeutic Goods Regulation 2008. • The pharmacist will remind the patient they will be followed up by the research team at 7 days. Female patients will be identified on presentation to the community pharmacy requesting re-supply of their oral contraceptive pill. Participants will be provided with two consent forms (one for the study and a second form from Services Australia allowing access to MBS and PBS data). They will be given the option of separate consent. The pharmacist will provide the participant with a location specific QR code for scanning on their mobile phone. This will open a secure webform hosted by the George Institute. The participant will then enter their personal details. They will then provide a finger signature and click submit for secure submission to The George Institute. The participant will be sent an SMS or email confirmation message with a validation code which they will provide to the pharmacy. Before consent may be obtained, pharmacists will provide the participant an opportunity to ask questions. On consent, the pharmacist will then proceed with the consultation, guided by an IT program, in a private consultation room in the pharmacy. Following this consultation, the pharmacist will make the appropriate clinical decisions and provide advice to the participant. The participant will be sent a 7 day follow up survey (via SMS, email or phone call as indicated by patient) to elicit adherence to medications and/or referral advice. A $20 fee will b paid for by the NSW Government to pharmacies, irrespective of the outcome of the consultation. The patient will need to pay for any medicines or products provided. In the ACT, there may be a cost to the consultation which will be paid for by the patient receiving the service, irrespective of the outcome of the consultation. A sample of participants will also be invited to participate in a semi-structured interview if they have indicated on their consent form they wish to participate. The intervention will be provided under the NSW Health Authority allowing participating NSW pharmacists to supply medications as part of the trial. (https://www.health.nsw.gov.au/pharmaceutical/Documents/pharmacist-ocp-authority.pdf). For ACT, a discretionary licence will be approved for participating pharmacies. (https://www.health.act.gov.au/sites/default/files/2023-02/Medicines%20Poisons%20Therapeutic%20Goods%20Licence%20Application.pdf). Implementation strategy There will be follow up training and ongoing support as part of implementation strategy Practice change facilitators will visit participating pharmacies to answer any queries, ensure quality data is being collected, and collect implementation data. The implementation component of the study will be underpinned by the Consolidated Framework for Implementation Research (CFIR), with the use of an adapted implementation model for community pharmacy. Implementation factors (barriers, causes and facilitators) and the Dougherty strategy classification systems, adapted to community pharmacy, will be used. On average, the facilitator will contact the pharmacy on a monthly basis. Pharmacies will be classified as low, medium or high contact based on several parameters including number of monthly consultations, number of pharmacists delivering the intervention, and the fidelity of consultation data. Targeted additional contacts will occur depending on this classification.