In the UK, in-house pharmacies must register with the General Pharmaceutical Council (GPhC). This registration ensures compliance with the Pharmacy Act 1983 and related regulations. The GPhC sets standards for pharmacy professionals and premises, covering areas like dispensing, storage, and staff qualifications. Regular inspections verify adherence to these standards.
Staffing and Qualifications
Your in-house pharmacy needs suitably qualified and registered pharmacists and pharmacy technicians. All staff must undergo appropriate training on handling controlled drugs and maintaining accurate records. The number of qualified personnel required depends on the pharmacy’s size and workload; GPhC guidelines provide detailed requirements. Failure to meet these standards can result in sanctions from the GPhC, including warnings, fines, or even closure.
Medication Storage and Handling
Stringent regulations govern how medications are stored and handled to maintain their quality and prevent misuse. Specific temperature controls are required for different drug types. Secure storage areas for controlled drugs, detailed inventory management, and robust security systems are mandatory. Regular stock checks and disposal procedures are also crucial aspects to follow.
Data Protection and Patient Confidentiality
Patient data privacy is paramount. Your in-house pharmacy must comply with the UK General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018. This means implementing robust systems to protect patient information from unauthorized access, ensuring secure data storage and transfer, and having transparent data handling policies.
Record Keeping and Reporting
Meticulous record keeping is non-negotiable. Accurate dispensing records, stock control logs, and staff training records are essential. Regular audits are advised to ensure compliance. You must report any serious incidents or breaches of regulations to the relevant authorities immediately. Failure to maintain accurate and up-to-date records can lead to regulatory action.
