8. The Responsible Pharmacist PDF

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The Responsible Pharmacist The Medicines Act 1968    

Requires a pharmacist is in 'personal control' of a retail pharmacy business in relation to the sale of ALL medicinal products - Pharmacist must be physical presence to sell ANY medicine 'Personal control' was abolished as it did not allow any absence from the pharmacy To improve the range of services available in a pharmacy - pharmacist needs to be able to work more flexibly (be able to leave the premises for a short period of time) There is need for better support staff e.g. technicians, dispensers, counter staff etc...

The Responsible Pharmacist Regulations 2008       

Came into force 1 October 2009 It a legal requirement for every retail pharmacy to have a named responsible pharmacist Statutory duty on the responsible pharmacist - ensure the safe and effective running of the pharmacy Regulatory guidance provided by DoH (Department of Health) Professional guidance has been provided by GPhC (General Pharmaceutical Counsel) Applies to all community pharmacies Applies to hospital pharmacies if registered with GPhC

What is responsible pharmacist?   

A responsible pharmacist is responsible for securing the safe and effective running of the pharmacy and during any periods of absence If there are two or more pharmacists - only one can be the responsible pharmacist A pharmacist cannot be responsible for more than one pharmacy at any one time

Role of a responsible pharmacist    

Secure the safe and effective running of the pharmacy, including during periods of absence Display notice with name, registration number and indication of being the in charge of the pharmacy at that time Complete the pharmacy record to identify who the responsible pharmacist is for the pharmacy at any one time Establish, maintain and review procedures for safe working

Absence from the pharmacy     

A responsible pharmacist can be absent from the pharmacy for up to 2 hours-during operational hours, between midnight and midnight Responsible pharmacist must only be absent if the pharmacy can continue to run safely and effectively, remain contactable and return with 'reasonable promptness' Where the responsible pharmacist is not contactable - another pharmacist is arranged to be contactable and to provide advice A pharmacist may need to be absent from a pharmacy for a number of reasons but must stay contactable

Tasks that can be carried out when responsible pharmacist is absent:  

GSL medicines can be sold P medicines cannot be sold

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Prescriptions can be taken in - assembling the medicines depends of many factors Dispensed and bagged prescriptions cannot be given out

Displaying a notice The notice must state:   

Pharmacist's name Pharmacist's GPhC registration number Saying he/she is in charge of the pharmacy at this time

The notice should be displayed even when the RP is absent from pharmacy. Pharmacy record The record must legally include:     

Pharmacist's name Pharmacist's GPhC registration number The date and time which pharmacist became the responsible pharmacist The date and time which the pharmacist ceased to be the responsible pharmacist If the pharmacist is absent - the date of absence, the time they left and the time they returned.

The record should be kept for 5 years by the pharmacy owner or Superintendent Pharmacist and be available for inspection. It is a legal required document - failure to complete the record is a criminal offence and can result in prosecution. Advice from GPhC:   

Record should be completed personally by the RP Amendments/alterations - should identified who made it Record should be completed at actual time - not retrospectively

Pharmacy procedures (SOP) What are SOPs:    

Establish, maintain and review procedures for safe working Covers a wide range of aspects relating to medicines include: ordering, storing, preparing, selling, supplying, delivering and disposal Covers circumstances where staff need to give advice about medicines Identifies pharmacy staff competent to undertake specific activities

What should there be SOPs for:   

Handling complaints and any incidents that indicate that the business is not running in a safe and effective manner (e.g. dispensing error) Arrangements which apply during the absence of the RP and the steps that need to be taken when the RP changes Procedure regarding how staff are notified of a change to the SOPs

Advice from GPhC: 

SOPs should be reviewed at least every 2 years

 

If a SOP is amended or reviewed by RP - there must be checks in place to show who amended it and the date it was amended SOPs should always be available for inspection

Further Advice from GPhC:   

Take on the role of RP if it in within your professional competence Only be RP at one pharmacy at a time Secure safe and effective running of the pharmacy business before undertaking any operational activities

No responsible pharmacist:   

The pharmacy must be closed for the sale and supply of medicines BUT this may violate the NHS contract to dispense Rx Displaying 'chemist' or 'pharmacy' in connection with the sale of goods is unlawful if there is no RP Safer to close the pharmacy but the NHS should be contacted first...