Clinical Screening of Prescriptions
The responsibility for the clinical screening of the prescription is with the pharmacy of the referring centre who have access to the patient clinical records. The clinical screen carried out by pharmacists at HaH must include as complete a clinical screen as possible with the information provided, and historic dispensing records. Where there is any ambiguity about dose or treatment regimen the HaH pharmacist must clarify with the prescriber or an individual from the referring centres clinical team who is authorised to act on behalf of the prescriber e.g., specialist nurse.
The HaH pharmacist must understand national and local prescribing protocols for the therapy areas e.g. BOPA standards for chemotherapy prescription verification. For therapies which require monitoring (e.g., cardiac, renal, hepatic or blood levels) prior to release of the prescription, the pharmacist must ensure monitoring levels have been checked before approving prescription for dispensing.
The HaH pharmacist will only allow supply from a prescription if the below particulars are complete;
- Patient’s Name;
- Date of Birth with age if under 12 or over 60 years of age;
- Patient’s hospital number and NHS number;
- Dated weight in kg (if a child under 16 or an adult where doses are dependent upon weight); height in cm where doses are dependent on surface area; Patient address;
- Allergy status and supply is not for containing any allergic product
- Drug Name, Form & Route
- Dose, Frequency and Quantity
- If an infusion, the rate or duration must be prescribed
- Consultant name;
- Prescribers Name
- Prescribers Qualification including Registered Number
- Date prescription signed
- Signature of prescriber
Additionally, the pharmacist will check that the dose prescribed is safe and licensed.
In the place dose or medicine is not licenced or off label the prescriber has given suitable reason for not prescribing a licenced medicine or off label. They also need to acknowledge prescribing off label or unlicensed medicines.
That any difference to the last prescription is clearly accounted for.
That suitable intervals between supplies are in place.
See SOP for Approving Prescriptions – SOP/PH/1665 or SOP for Cancer Pharmacist Prescription Verification
Legal Status of Medicines Supplied
- Medicines supplied in manufacturer’s original packaging will have the legal category of the medicine printed on the packaging. The legal categories include:
- Prescription Only Medicines (POM) o Pharmacy Only (P)
- General Sales List (GSL)
- Many of the products are supplied as Specials and as such the customer remains legally responsible for safety, efficacy and quality.
Quality of Medicines
- All products supplied must comply with the appropriate BP monograph when available and general monograph, compliance is assured by the following.
- All materials used are either:
- Licensed pharmaceutical products or,
- Specials manufactured by an approved manufacturer and authorized for use by an appropriate Quality Assurance Service and accompanied by an appropriate certificate of analysis, and audit of service
- All devices/containers are CE marked and are approved for use by an appropriate Quality Control body.
- All infusions are made by an addition of the drug to the bag up to the maximum allowed by the bag manufacturer. If the addition is greater than 10% of the original bag volume, then the final volume including the addition is specified on the label.
- All procedures, personnel and premises are fully validated. Manufacturing and analysis (where appropriate) have been carried out in accordance with Good Manufacturing Practices and the relevant Manufacturing License.
- All finished products are as stated on their respective labels. The finished product assessment embraces all relevant factors including:
- Manufacturing conditions (both physical and microbiological) o A review of manufacturing and packaging documentation, o Review and validation of staff competency
- Examination of the finished product and compliance with the finished product specification
- volume or weight
- device integrity
- secondary packaging integrity
- visual inspection of product and label o prescription/order check
- All products must be supported by stability data appropriate for the stated shelf life of the product.
- Containers are as specified and free from leaks on leaving the manufacturing site.
- Chemical Analysis is carried out on all aseptic products that have undergone a bulk dilution stage and are subsequently filled by an automated method.
- A comprehensive environmental monitoring programme covers both active and passive monitoring in the manufacturing unit’s manned and unmanned states. On a session basis, finger dabs, contact and settle plates are carried out. In addition, an end of process broth transfer is performed to verify sterility of the closed system used during manufacture.
- Microbiological data is monitored retrospectively. All results are examined critically, and users will be informed should any risk to product quality and/or patient safety arise.
- All staff must undertake an initial comprehensive three-month staff training and competency assessment. They then progress through a two-year training programme to qualify in aseptic preparation. Regular retraining, assessment and re-validation are carried out.
- All transport, unless otherwise stated, is by refrigerated vehicles unless the product is chemically/physically unstable at 2-8ºC. Delivery routes are regularly validated for temperature and quality.
- Packaging materials are reusable and/or recyclable (bar UV light protected bags).
- This comprehensive approach to quality is integral to the systems that underpin the MHRA “Specials” Manufacturing license.