Serious shortage protocols (SSPs) Flashcards
what is serious short protocol?
Enables Ministers, in the event of a medicine (POM) being in serious shortage, to issue protocols to allow community pharmacies to dispense against a specific protocol instead of a prescription without going back to the prescriber first
Each protocol would set out precisely what action pharmacists can take, under what circumstances and for which patients. Each protocol is also expected to be time limited
Some products, such as those for epilepsy and CDs, will not be covered by SSP’s, and patients will have to be referred back to their prescriber
what items are not covered in SSP?
Some products, such as those for epilepsy and CDs, will not be covered by SSP’s, and patients will have to be referred back to their prescriber
What alternatives can be dispensed?
An alternative quantity - to ensure any remaining stock is retained by community pharmacies for supply to patients who have particular need of it
An alternative formulation - if there is or may be a serious shortage of one formulation (e.g. capsule), another formulation may be supplied
An alternative strength - if there is or may be a serious shortage of one strength (e.g. 20mg), a different strength may be supplied (e.g. 10mg); the dose remains that prescribed by the doctor (on the prescription)
A generic equivalent - a generic equivalent (or branded equivalent) or the separate constituent parts of the product may be supplied
A therapeutic equivalent - a therapeutic equivalent (i.e. a medicine with a different active substance) may be supplied
does the dispensed SSP product need to be labelled?
The dispensed SSP product must be labelled to show that supply has been made in accordance with the SSP and identify the SSP (usually by its number)
The prescriber of the original product (that has not been dispensed) may need to be notified
For reimbursement and remuneration, the appropriate endorsement must be made following the supply of the alternative
Pharmacists must consider the SSP and, if, in their opinion – exercising his/her professional skill and judgement – the alternative is reasonable and appropriate for the patient, they may supply the alternative (only as specified in the SSP and subject to any conditions in the SSP), provided that the patient consents/agrees to the alternative SSP supply
do you need to use SSP?
If an SSP is in place, pharmacy owners do not have to use it. If a pharmacist is of the opinion in the exercise of his/her professional skill and judgement that supplying a different product or quantity is unreasonable or inappropriate and is able to supply the prescribed product or quantity within a reasonable timescale, they are allowed to do this
Similarly, if a pharmacist is of the opinion that supplying a different product or quantity under a SSP is unreasonable or inappropriate and is unable to provide a different product within a reasonable timescale, a supply under the SSP can be refused. In that case, the patient must be referred back to the prescriber
endorsements for SSP?
Community pharmacy contractors are required to endorse the paper prescription, or the electronic prescription, or alternatively using the EPS dispensing token with the following information:
SSP [followed by the three-digit reference number applicable to the SSP] to indicate that the supply was made in accordance with an SSP For example, SSP007 for Fluoxetine 30mg capsules would be endorsed as ‘SSP 007’;
Details of product supplied in accordance with the SSP(drug name, quantity, strength, formulation, supplier name or brand)*;
Quantity supplied*;
Pack size– best practice where multiple pack sizes are available; and
Invoice price– only if NHSBSA has no list-price available on dm+d.
*The drug details and quantity supplied and endorsed will depend on the relevant SSP.
A community service is currently being reviewed to understand if a PGD is still the most appropriate method of medicines supply
What needs to be considered when undertaking this review?
Who should be involved?
Answers:
Legislation (does it comply?), is it in line with guidelines?, governance, review of the service (is it still necessary? Is it still the most appropriate method of supply? Any other options? How often is it used….?)
Commissioner and provider, health professionals working in the service, relevant stakeholders
A nurse works in a clinic using PGDs to supply injections for self-administration by the patient. A patient attends and asks if the district nurse can administer the injection instead.
Can the district nurse make this supply?
Registered health professionals using PGDs can only do so as named, authorised individuals. They are not able to assign or delegate their responsibility to another person
The PGD inclusion criteria should clearly state that patients would only be included if they are competent to self-administer
Need to consider why patient wants the district nurse to administer the injection
A pharmacist working in an NHS Trust has been asked to be the pharmacist signatory on some PGDs which have already been developed by a PGD working group.
What does the pharmacist need to consider?
Answer:
What are they signing for? Is there a PGD policy? Do they feel competent to undertake the role? If neither of these are in place or unclear then the pharmacist should not sign the PGD
- Should the pharmacist signing the PGD have also been involved in developing the PGD?
This is not required by legislation
But the PGD should be drawn up by a multidisciplinary group involving a doctor, a pharmacist and a representative of any other professional group expected to supply medicines under the PGD
A PGD is being used to supply a medicine that is for children aged from 3 months to 12 years of age. A mother attends the clinic with her 2 month old child. All criteria included in the PGD are met, except for the child’s age.
Can the health professional make a clinical judgement to supply the medicine under a PGD?
No, this is not legal. The patient must meet the criteria exactly as stated in the PGD. The health professional cannot use their clinical judgement to determine that the medicine can be supplied
- What if the health professional working under the PGD was an independent prescriber? Can the medicine be supplied to the child in this case?
No, for the same reasons stated in question 1. The PGD must be followed exactly if the health professional is working under the PGD. If the health professional is an independent prescriber and competent to prescribe, they should not be working under a PGD
- What options are available to the health professional?
- When reviewing your records, there seems to be a high proportion of patients being referred to an alternative provider because they don’t meet the PGD criteria. What should you do?
Not supply the medicine under the PGD, so refer to another health professional or provider (legal requirement that the referral information is included in the PGD)
Discuss this with whoever developed the PGD, check if the PGD service has been evaluated, or if it needs redesigning, is it still fit for purpose?
A PGD was authorised for use before April 2021 and it is close to its expiry date. The PGD will automatically be authorised for another year. What are the potential risks of doing this?
Important new evidence may not be identified
May be changes to the drug indications
Therefore, PGD should be reviewed and updated. Remember to update all relevant documents and get new signatures for all those involved in the PGD
I have received a prescription for ‘Drug X’ 28 tablets. I only have 14 tablets in stock, however, there is a valid SSP in place for ‘Drug X’ allowing substitution of tablets to capsules. Can I dispense the 14 tablets of ‘Drug X’ that I have in stock and use the SSP to supply the remaining balance as capsules?
No. Should you wish to use the stock you currently have on your shelf you should dispense the prescription as per usual processes, clearly endorsing the quantity to show that 14 tablets only were dispensed. Alternatively you can consider supply of the capsules in accordance with the SSP for ‘Drug X’ .
