Standards › Standard 54 › Standard operating procedures (SOPs)
SOP · DRM-SOP-003 · Version 1.0 · Approved by the ASF Expert Committee
Supports: 54.4
At a glance
- Systemic drugs with monitoring needs (for example isotretinoin) are prescribed under a written protocol (HOS-POL-001).
- Pregnancy prevention and the required blood tests are set before the first dose (DRM-FRM-002).
- Monitoring tests are repeated at the interval in the protocol, and the results are reviewed.
- A result outside the limit stops or changes the treatment until reviewed.
- Stop and get help straight away if: a systemic drug with monitoring needs is started without the required tests and pregnancy prevention checks.
1. Purpose
To make sure systemic dermatology drugs are monitored and safe to continue (54.4).
2. Scope
| Applies to | Clinical and support staff in the hospital |
| Locations | All wards, clinics and departments of the facility |
| When | Whenever the activity described is carried out |
| Does not apply to | Activities covered by another document listed in section 15 |
3. Definitions
| Term | Meaning |
|---|---|
| Clinical lead | The doctor or nurse in charge of the area at the time |
4. Background
To make sure systemic dermatology drugs are monitored and safe to continue (54.4).
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Dermatologist | Prescribes and reviews each monitoring result | Clinical lead |
| Ward pharmacist or nurse | Schedules the tests and tracks their results | Dermatologist |
6. Materials and equipment
| Item | Requirement | Condition |
|---|---|---|
| Records and forms named in this document | Current version | Checked before use |
7. Safety
- Stop and call for help if a patient is at immediate risk. Do not delay urgent care to complete paperwork.
8. Before you start
- Confirm the forms and equipment named in this document are available and current.
9. Procedure
Step 1. Set up.
- Set the required tests and the pregnancy prevention plan before the first dose.
Key point: Set up.
Step 2. Monitor.
- Repeat the tests at the protocol interval and record the results (DRM-FRM-002).
Key point: Monitored.
Step 3. Act.
- Stop or change the treatment when a result is outside the limit, until reviewed.
Key point: Acted.
10. Decision points
- No decision points in this procedure.
11. Special situations
| Situation | Action |
|---|---|
| Out of hours | Follow the same steps. Use the on-call contact on the wall of the area. |
12. Escalation
- Any serious problem goes to the duty clinical lead at once and to the clinical director the same day.
13. Monitoring
| Measure | Target | Frequency | Owner | If not met |
|---|---|---|---|---|
| Patients with tests and pregnancy prevention recorded before the first dose | 100% | Monthly | Clinical lead | Hold the first dose |
| Monitoring tests done on schedule | 100% | Monthly | Ward pharmacist | Escalate to the dermatologist |
14. Records
| Record | Kept in | Retention |
|---|---|---|
| Record named in this document | Patient record or the area file | the period set by the facility’s records policy years |
15. Training
- Staff are trained in this document at induction and refreshed each year, with a recorded competency check.
16. Related documents
| ID | Title | Use |
|---|---|---|
| DRM-FRM-002 | Systemic drug monitoring and pregnancy prevention record | Record |
| HOS-POL-001 | Medicines management policy (existing, reused) | Policy |
17. Evidence
| Reference | Note |
|---|---|
| E-006 | ASF Policy Framework v1.2. Adapted. |
| E-009 | ASF Expert Committee consensus. |
18. Change history
| Version | Date | What changed | Approval |
|---|---|---|---|
| 1.0 | the date of approval | First version | set Expert Committee approval |
E-learning for this document
References
- Accréditation Sans Frontières (2026). ASF Policy Framework v1.2. (E-006)
- Accréditation Sans Frontières (2026). ASF Expert Committee consensus on Standard 1. (E-009)