Testosterone Replacement Therapy: Delivering the Private PGD Service Safely

About this service

Testosterone deficiency, also known as hypogonadism, is an increasingly diagnosed condition in adult men. It is characterised by consistently low serum testosterone combined with characteristic symptoms including reduced libido, loss of early morning erections, fatigue, low mood, reduced muscle mass, and impaired concentration. The British Society for Sexual Medicine (BSSM) 2023 guidelines and the Society for Endocrinology 2021 guidance provide the current UK evidence base for diagnosis and treatment.

Community pharmacies are playing an expanding role in delivering testosterone replacement therapy (TRT) through private Patient Group Directions (PGDs). A PGD is a written instruction that allows specified registered healthcare professionals, including pharmacists, to supply or administer a named medicine to a defined group of patients without an individual prescription for each patient. PGDs are authorised by a responsible body and must be signed by each individual pharmacist before any supply is made. A pharmacist who has not personally signed the current, active PGD must not supply testosterone under it.

The scope of pharmacy-led TRT services varies between organisations. Some PGDs authorise ongoing supply only to patients already diagnosed and initiated by an authorised prescriber. Others explicitly authorise pharmacist-led initiation of treatment following a structured assessment. Whether initiation is within scope depends entirely on the wording of the specific PGD. Pharmacists must not assume that supply includes initiation unless the PGD explicitly states this. Where there is any ambiguity about scope, the pharmacist should seek written clarification from the responsible body before offering the service.

PGDs are primarily designed for defined patient groups in relatively straightforward clinical situations. Their use for ongoing management of a chronic endocrine condition such as testosterone deficiency sits at the more complex end of the PGD framework. Service availability therefore depends on organisational governance approval, indemnity arrangements, and PGD authorisation. Pharmacists must practise within their own indemnity arrangements, their organisational governance framework, and the specific terms of their PGD at all times.

This article reflects common frameworks used in private UK TRT PGD services, drawing on BSSM 2023 and Society for Endocrinology 2021 guidance. The clinical thresholds described, including testosterone levels and monitoring parameters, are derived from these guidelines but individual PGDs may specify different thresholds, products, and criteria. Pharmacists must follow the exact wording of their own PGD and must not apply BSSM thresholds as if they were universal PGD criteria.

Who to offer the service to

Include

• Adult males aged 18 years and over (or the lower age limit specified in the PGD)
• Biochemically confirmed testosterone deficiency as defined by the PGD: typically total testosterone below the laboratory reference range on at least two separate early morning fasting measurements, taken at least four weeks apart
• Consistent symptoms of testosterone deficiency confirmed using a validated tool such as the Androgen Deficiency in the Ageing Male (ADAM) questionnaire or the Ageing Males' Symptoms (AMS) scale
• Baseline investigations completed prior to first supply: PSA, haematocrit, LH, FSH, and prolactin where required by the PGD
• Initial clinical assessment and, where the PGD requires it, diagnosis confirmed by an authorised prescriber or service clinician prior to pharmacy supply
• No current contraindications to testosterone therapy as defined within the PGD
• Informed consent given, risks and monitoring requirements explained, and monitoring schedule agreed

Exclude

• Prostate cancer (active, locally advanced, or metastatic), or PSA above the threshold specified in the PGD without prior urological review
• Male breast cancer (current or previous)
• Haematocrit above 54%, or above the threshold specified in the PGD
• Severe chronic heart failure (New York Heart Association Class IV)
• Current or anticipated desire to father children: testosterone suppresses spermatogenesis and may impair fertility for the duration of treatment and potentially beyond
• Testosterone level within the normal range as defined by the laboratory or PGD, without confirmed free testosterone deficiency
• Untreated severe obstructive sleep apnoea
• Raised prolactin or secondary hypogonadism with low LH and FSH not yet investigated: refer to endocrinology before initiating TRT
• Pituitary adenoma not excluded where clinically indicated
• Current use of anabolic steroids or exogenous androgens
• Age under 18, or under the lower age limit specified in the PGD

How to deliver the service

1. Confirm PGD authorisation and your own competency Before beginning the consultation, confirm you have personally signed the current, active PGD and that your name appears as an authorised signatory. Check the PGD expiry date. Confirm the PGD covers this patient group, this product, and this clinical scenario. Confirm your training is current and that you feel competent to assess and supply testosterone to this patient under this PGD. If you have not signed the PGD, or if there is any doubt about the scope of the service, do not supply. Refer the patient back to the prescribing or organising service. Supplying testosterone without personal PGD authorisation constitutes supply without legal authority.
2. Review biochemical confirmation Confirm the patient has at least two documented total testosterone measurements that meet the deficiency threshold specified in the PGD, both taken before 11am on separate days at least four weeks apart, with fasting samples preferred. Note the exact values, dates, and times of sampling. A single testosterone level is not sufficient for diagnosis under BSSM 2023 guidance. Where the total testosterone falls in the borderline range (typically 8 to 12 nmol/L by BSSM criteria), sex-hormone-binding globulin (SHBG) is required to calculate free testosterone, as SHBG profoundly affects the amount of biologically active testosterone. High SHBG (common in older men, liver disease, and hyperthyroidism) can leave free testosterone deficient despite a borderline total level. Low SHBG (common in obesity and type 2 diabetes) can mean adequate free testosterone despite a low-appearing total. The BSSM 2023 cut-off for free testosterone deficiency is below 0.225 nmol/L, but the PGD may specify a different threshold.
3. Symptom review Review the patient's symptom burden using a validated tool. The AMS scale scores 17 symptoms across somatic, psychological, and sexual domains and provides a quantitative baseline for monitoring treatment response over time. The ADAM questionnaire is a shorter 10-item alternative. Document the score at each assessment. Patients with borderline testosterone levels but a high symptom burden and confirmed free testosterone deficiency may benefit from a trial of therapy. Improvement in AMS or ADAM score at 3 to 6 months provides an objective measure of treatment response.
4. Contraindication screen Work through the PGD exclusion criteria systematically. Ask specifically about prostate symptoms, any history of prostate or breast cancer, known cardiovascular disease, heart failure severity, sleep quality and any symptoms of obstructive sleep apnoea (snoring, witnessed apnoeas, excessive daytime sleepiness), current desire for fertility, and current medication including anabolic steroids. Review the most recent PSA and haematocrit results. Where the PGD requires endocrinology involvement for secondary hypogonadism (low testosterone with low or low-normal LH and FSH), confirm this has occurred before supply. If there is any doubt about whether an exclusion criterion applies, do not supply and refer back to the prescribing service.
5. Counsel the patient on benefits, risks, and formulation Confirm the patient has received and understood the following information and document that this has been done.\n\nFormulation: transdermal gels (such as Testogel or Tostran) require once-daily application to clean dry skin on the shoulders, upper arms, or abdomen. Hands must be washed immediately after application and the site covered to prevent interpersonal transfer of testosterone to female partners, children, or other household contacts, which can cause virilisation. Testosterone undecanoate injection (such as Nebido) is given typically every 10 to 14 weeks; the long duration of action means that if adverse effects occur they cannot be rapidly reversed. Testosterone enanthate injections are given every 2 to 3 weeks and cause greater fluctuation in levels.\n\nCardiovascular health: current evidence does not demonstrate increased cardiovascular risk from TRT in men with confirmed deficiency, and some data suggest benefit; however, men with established cardiovascular disease should remain under appropriate medical supervision throughout treatment.\n\nSleep apnoea: TRT may worsen obstructive sleep apnoea during treatment. Ask at each review about sleep quality, snoring, and daytime sleepiness. If symptoms develop or worsen, refer for sleep assessment.\n\nMood and behaviour: some men experience increased irritability, mood changes, or in higher doses aggressive behaviour during TRT. Patients and their partners should be aware of this possibility and report significant mood changes at review.\n\nSkin and physical effects: acne, increased body or facial hair, and oedema are recognised side effects. Gynaecomastia (breast tissue enlargement) can occur due to peripheral conversion of testosterone to oestradiol and should be reported.\n\nFertility: TRT suppresses spermatogenesis and may impair fertility for the duration of treatment and potentially for months or years after cessation. Men who wish to father children should not use TRT.\n\nBlood donation: patients should check current NHS Blood and Transplant or donor service guidance on eligibility. Eligibility may vary depending on the underlying condition, treatment stability, and current donor service criteria.
6. Supply and document Supply the product and dose specified in the PGD only. Document the consultation fully on the pharmacy clinical record: both testosterone values with dates and times, AMS or ADAM score, PSA and haematocrit values with dates, contraindication screen completed with each exclusion criterion reviewed, product and quantity supplied, counselling provided, PGD reference number and version, your signature confirming supply under the PGD, and the date of the next monitoring review. The monitoring schedule for established patients typically follows the pattern specified in the PGD, usually at 3 months, 6 months, 12 months, then annually.

Assessment Findings and Actions

Testosterone Thresholds: BSSM 2023 Reference Framework

These values reflect BSSM 2023 guidance and are provided as a clinical reference. Individual PGDs may specify different thresholds based on laboratory reference ranges, service design, or local governance decisions. Always follow the PGD exactly.

SHBG is important in borderline cases. High SHBG (liver disease, older age, hyperthyroidism) may leave free testosterone deficient despite a borderline total. Low SHBG (obesity, type 2 diabetes) may mean adequate free testosterone despite a lower total level. Free testosterone calculator available at issam.ch/freetesto.htm.

TRT Formulations Available in the UK

Short-acting formulations are preferred on initiation so treatment can be adjusted or stopped rapidly if adverse effects occur. Specific products and doses are defined in the PGD.

Monitoring Schedule: Established TRT Patients

Recording and submission

• Date, time, and result of both pre-treatment testosterone measurements, confirming early morning fasting sampling and the interval between them
• AMS or ADAM score at baseline and at each review, to allow objective monitoring of treatment response
• Baseline PSA, haematocrit, LH, FSH, and prolactin results (dates and values); SHBG where calculated for borderline cases
• Contraindication screen: each PGD exclusion criterion reviewed and recorded, including the fertility discussion
• Whether supply is continuation of established treatment or first supply under the PGD; if first supply, confirm the PGD authorises this
• Product, formulation, dose, and quantity supplied, exactly as specified in the PGD
• PGD reference number, version date, and pharmacist signature confirming supply under the PGD
• Counselling points covered, including cardiovascular considerations, sleep apnoea risk, mood effects, fertility, and formulation-specific points
• Any adverse effects reported at review and action taken
• Date of next monitoring review agreed with patient

Key takeaways

• You must personally sign and be named on the active PGD before supplying testosterone. Whether your PGD authorises supply, continuation, or initiation depends on its exact wording: check the scope before offering the service.
• Diagnosis requires two early morning fasting testosterone measurements at least four weeks apart, with borderline cases requiring free testosterone calculation using SHBG. Thresholds in this article follow BSSM 2023 guidance and may differ from those in your PGD.
• Monitor haematocrit and PSA at each review. Haematocrit above 54% or a significant PSA rise requires contacting the prescribing service before the next supply. Testosterone can also worsen sleep apnoea and cause mood changes: ask at every review.

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