Retail and Ermergancy Supplies - exemptions

5 exemptions to restrictions on sale, supply and administration

1. Sale of GSLs without supervision of a pharmacist e.g in supermarket

2. Patient Specific Direction

3. Patient Group Direction

4. Optometrist/Podiatrist or podiatrist signed patient orders

5. Supply of medicines to school - signed order

PSD

• written instruction from a doctor, dentist or non medical prescriber for a medicine to be supplied or administered to a named patient after having been assessed on an individual basis

• Organisations can choose to limit who is authorised to supply / administer medicines under a PSD

• PSD must contain enough info for person to safely administer the medicines - verbal,written

PGD

• written direction that allows the supply/administration of a specified medicine by named authorised health professionals to a well defined group of patients requiring treatment for a pacific condition

• E.g baby immunisation/ seasonal vaccines or oral contraception

• Pharamcy Frst supply of nitrofurantoin or uncomplicated UTI

What limitations are there to the administration and supply of medicine under PGD and PSD ?

• Administration : P or GSL medicines can be administered without PGD or PSD

• Supply: P medicines require PGD or PSD unless an exemption applies or supply is made from a registered pharmacy under supervision of a responsible pharmacist - pre packed GSL medicines can be supplied without a PGD

Optometrist or Podiatrist signed patient orders

• Optometrists and podiatrist cannot authorise supplies of POMs by writing prescriptions unless they are additionally qualified as independent or supplementary prescribers

• Pharmacist working in a registered pharmacy can supply certain POMs directly to patients in accordance with a signed patient order from any registered podiatrist or optometrist

• Medicine must be from a list of medicines that can be legally sold by the op/pod rather than just one they can administer

• E.g chloramphenicol 0.5% eye drops for conjunctivitis or miconazole for athletes foot

Supply of Medicines to schools - signed order

• adrenaline/salbutamol from a pharmacy via a signed order

• Emergency supply

• Signed order must contain : school name, product details, strength, purpose, total quantity, signature of head teacher, letter headed paper

• Must retain SO for 2 years from the date of supply

The exemption of Naloxone

• Naloxone - an opioid/opiate antagonist which can completely or partially reverse the CNS depression - used in the treatment of suspected opioid overdose

• Individuals employed or engaged in lawful, recognised drug treatment centres can obtain Naloxone from a wholesaler and make direct supplies to patients without the need of a prescription, PGD or PSD

Wholesaling exemption

• anyone trading medicines other than to a patient must :

• have a wholesale license

• Comply with Good Distribution Practice Standards and pass inspections

• Have a suitable RP to ensure suitable procurement, storage and distribution of medicines

Serious Shortage Protocol (SSP)

• 2019 amendment to the Human Medicines regulations 2012 to introduce SSPs

• Sale or supply by or under the supervision of a pharmacist in accordance with a SSP - in the event of a shortage of a POM

• Allows different strengths, quantities or form of POM to that prescribed

• Different brand or POM

• Supervising Pharmacist must use professional judgement and skill to determine that the substitution is appropriate

• Patient also needs to agree to the switch

Emergancy Supply at the Request of a Prescriber

To supply POM in the absence of a Prescription - in an Emergancy at the request of a patient or prescriber

• case by case basis - professional judgment - best interest of the patient

Criteria :

• Written prescription cannot be provided immediately due to an Emergancy event

• Prescription must be provided however within 72 hours after request

• Medicine must be supplied in accordance with directions given by the prescriber

• NO CDs except Phenobarbital

• NO. Sch1,2,3 CDs

Emergancy Supply at request of prescriber Records must contain …

• date POM supplied

• Name of medicine inc strength and form and quantity

• Name and address of prescriber requesting medicine

• Name and address of patient

• Date of prescription

• Date of when prescription was received

Emergency Supply at request of Patient

• case by case basis

• Professional Judgement

Criteria :

• interview patient

• Must demonstrate immediate need for POM and evident that prescription is not practical to obtain

• previous treatment evidence - UK, EEA or Swiss health professional

• Dose - summary care records

Max length of Emergency Supply at request of patient

• Sch 4 or 5 CDs : max 5 days

• POM : Max 30 days

• Insulin, ointment, cream, inhaler - smallest pack possible

• Oral contraceptive - full treatment cycle

• Antibiotic - smallest quantity or full treatment

Records - Emergency supply at Patient’s request

• made in POM register on the day of supply

Must include :

• date of POM supply

• Name and quantity of medicine supplied

• Name and address of the patient

• Info on the nature of the emergency

Emergency supply label must be added to dispensing label

Standard Operating procedures - SOPs

• written instructions on how to carry out a routine task - when, where and by whom

• Clinical governance - management of risk and harm minimisation

Benefits of SOPs

1. Standardisation of processes and practice towards a specific outcome

2. Maintains consistency

3. Improve quality assurance and safety

4. Saves time/training needs/cognitive workload

RPS Error reporting Guidlines

1. Take steps to let the patient know promptly

2. Make things right - contacting prescriber

3. Offer an apology

4. Let colleagues involved in the error know

Criteria for justified legal defence for honest dispensing error

1. Dispensed in registered pharmacy

2. Dispensed under supervision of registered pharmacist

3. Supplied against prescription, PGD or direction of prescriber requesting medicine

4. Promptly notified to patient once pharmacy team are aware of error