SOPs and sale of medicines protocol (SOMP))

Question 1

What is the definition of SOPs (3)

Answer 1

1. Standard Operating Procedures(SOPs)
2. written by the superintendent pharmacist
3. specify what procedures should be followed in the pharmacy when and by whom.

Question 2

What are the legal requirements surrounding SOPs (2)

Answer 2

1. The General Pharmaceutical Council (GPhC) has a requirement that all pharmacies have SOPs in place to cover the dispensing process.
2. The GPhC require that every step in the dispensing process should have an SOP, for example, from taking in a prescription, dispensing it, through to issuing the dispensed items to a patient or their representative.

Question 3

What is the purpose of SOPs (5)

Answer 3

1. To ensure everyone in the pharmacy is providing their customers with the same standard of service.
2. It is important to follow your SOPs at all times as they tell you exactly how to do your job and when you should refer to the pharmacist.
3. Most importantly SOPs are there to maintain the safety of the public
4. Reduce risk of error
5. Remember to always refer to and follow your pharmacy’s SOPs.

Question 4

What is the Sale of medicines protocol (3)

Answer 4

1. In place to ensure that medicines are sold appropriately to members of the public.
2. All members of the pharmacy team who are involved in the sale of medicines must follow the SOMP when recommending and selling medicines over the counter.
3. You can only start to sell medicines and give advice to customers once you have read, understood and signed your pharmacy’s SOP on the sale of OTC medicines.

Question 5

What will most SOPs and SOMPs include (7)

Answer 5

1. When you can sell medicine and to whom
2. When to refer customers to the pharmacist
3. WWHAM questioning when selling OTC products (or alternative questioning frameworks)
4. How to deal with requests for medicines by name
5. Giving correct information following the sale of an OTC product
6. Maintaining patient confidentiality
7. Handling prescriptions

Question 6

When can you sell P medicines (4)

Answer 6

1. Only sell P medicines under the supervision of the pharmacist
2. pharmacist is on the medicines counter
3. pharmacist is in the dispensary.
4. If you sell a P medicine in the absence of a pharmacist, you are breaking the law, even if you feel confident that the product is suitable for the customer.

Question 7

When do you refer a customer to the pharmacist (2) and how (4)

Answer 7

1. Refer if you are unsure about the symptoms that the customer is presenting with or if you are not sure of suitable products to recommend
2. Refer if the patient has asked for information that you are unsure about or not confident in giving
3. Always tell the customer if you are referring them and why
4. Provide the pharmacist with all the information that you have obtained from the customer
5. Listen carefully to the pharmacist’s response and reply accordingly to the customer
6. Follow the course of action the pharmacist has recommended

Question 8

What following groups of people must the pharmacist be consulted prior to selling medicines (4)

Answer 8

1. Babies and children
2. Patients with another condition such as diabetes, asthma, high blood pressure etc..
3. Patients on one or more medications for long term conditions
4. Pregnant or breastfeeding women

Question 9

What signs and symptoms require referral to the pharmacist (6)

Answer 9

1. Visual disturbances
2. Unexplained, sudden weight loss
3. Severe pain
4. Unexplained bleeding
5. Loss of appetite
6. Persistent symptoms that have lasted longer than expected for a particular condition, for example, cough, high fever

Question 10

What are the WWHAM questions

Answer 10

W - who is the medicine for

W - what are the symptoms

H - how long have the symptoms been present

A - actions that have been tried already

M - medication they are taking for this or any other mediciation

Question 11

When must the patient be referred to the pharmacist in relation to who the medicine is for (7)

Answer 11

1. Under 12 years old
2. Pregnant or breast feeding
3. Over 60 years old
4. Buying excessive quantities of products or buying too often
5. Requesting the morning after pill
6. Newborn or very young babies
7. Affected by vision impairment

Question 12

When must the patient be referred to the pharmacist in relation to what the symptoms are (8)

Answer 12

1. Has severe pain
2. Has pain that started suddenly
3. Has recurring symptoms
4. Has shortness of breath
5. Has dizziness
6. Has bleeding
7. Has symptoms that you are unsure about or you think are more serious in nature
8. Has unexplained weight loss

Question 13

When must the patient be referred to the pharmacist in relation to how long symptoms have been present (3)

Answer 13

1. Cough longer than 3 weeks
2. Cold sores more than 10 days
3. minor conditions lasting more than a couple of weeks (depending on the condition)

Question 14

When must the patient be referred to the pharmacist in relation to actions already taken

Answer 14

Asking for a product that is NOT known to relieve symptoms that the customer is complaining of

Question 15

What points are there to consider when giving the correct information following the sale of an OTC product (7)

Answer 15

1. Make sure the customer knows the correct dosage and understands how to use it. Most of this information is on the packaging or in the PIL – point this out to the customer
2. Advise when to take the medications, for example with or after food, and how to take it, for example, ‘swallow whole’ or ‘do not chew’
3. Depending on the product being sold, provide cautionary advice, for example for paracetamol, ‘do not take more than 8 tablets in 24 hours and not more than 2 at any one time’
4. Advise on warnings, storage and what other medicines should be avoided. For example, to avoid other paracetamol – containing products when paracetamol is sold
5. Tell the customer about any possible side effects, for example to avoid driving if the medicine causes drowsiness. Remember that side effects vary from person to person and not everyone will experience side effects
6. Refer customers to the pharmacist if their symptoms persist for longer periods or symptoms worsen. Also, refer anyone who is experiencing breathing difficulties, swelling of the face, mouth or throat or suffering an allergic reaction
7. Provide up-to-date and relevant information or healthcare leaflets to customers seeking more information on the OTC products being sold

Question 16

How do you maintain patient confidentiality (8)

Answer 16

1. You should not discuss patient information, including patient names, or details of your working day with anyone outside of work or mention any details on social media
2. Handle requests regarding information about a patient or customer with care
3. You must not disclose any information that you have access to or have been trusted with.
4. Explain politely to the representative that information cannot be provided about the patient due to confidentiality legislation and refer them to the pharmacist
5. Confidentiality also applies to authorities such as the police.
6. A police officer can not ask for patient data, unless correct documents are provided and are checked by the RP
7. Under GDPR, you must not disclose patient details to anyone other than the patient
8. Some customers may be embarrassed to talk about their symptoms at the pharmacy counter, when others are around. In such situations, respect their confidentiality, and ask if they would prefer to talk in the designated consultation area instead.

Question 17

When can you disclose information with colleagues (3)

Answer 17

1. You may be able to share customer information with your colleagues as they are bound by the same confidentiality as you.
2. For example you may want to leave a query or check for more information with another colleague.
3. Always check with your pharmacist which members of the pharmacy team such queries should be discussed with.

Question 18

What is the importance of confidentiality (3)

Answer 18

1. Confidentiality is a legal requirement for people working in any health-care role.
2. It is also an ethical requirement to maintain confidentiality because customers put their trust in you when they provide you with personal information about their health.
3. The public may lose confidence in the pharmacy profession if we do not protect their personal information.

Question 19

What is confidentiality (2)

Answer 19

1. Confidentiality is a key data protection requirement and an essential professional obligation in pharmacy.
2. Patients/customers using your pharmacy need to feel confident that their personal data will be processed safely and securely.

Question 20

What is processing data (6)

Answer 20

1. the collection
2. recording
3. management
4. storage
5. disposal of an individual’s personal data.
6. Any organisation processing personal data must comply with the GDPR.

Question 21

What is personal data (2)

Answer 21

1. personal data is ‘any information relating to an identified or identifiable natural
2. person’ – this means that if an individual can be identified directly/indirectly by information held, that information is considered to be personal data.

Question 22

What are the special categories of personal data (6)

Answer 22

1. include genetic data
2. biometric data
3. data relating to physical/mental health conditions
4. information highlighting the racial or ethnic origin of an individual.
5. Information that pharmacies hold about their patients’ health falls into a special category of personal data.
6. Processing of special categories of personal data is subject to stricter conditions than other personal data.

Question 23

What are the formats of personal data in the pharmacy (8)

Answer 23

1. CCTV footage
2. computer application data
3. patient medication record (PMR) system
4. emails
5. faxes
6. handwritten/printed data kept in manual filing systems
7. prescriptions
8. voicemails

Question 24

What are the data protection principles of the GDPR, which require that personal data must be: (6)

Answer 24

1. Processed, lawfully, fairly and in a transparent manner
2. Collected for specified, explicit and legitimate purposes
3. Adequate, relevant and limited to what is necessary in relation to the purposes of processing
4. Accurate and, where necessary, kept up-to-date
5. Kept in a form which allows the identification of an individual for no longer than is necessary
6. Processed in a manner that ensures appropriate security

Question 25

What are the six lawful bases for processing an individual’s personal data under the GDPR (7)

Answer 25

1. The data subject has given consent
2. Processing is necessary for the performance of a contract
3. Processing is necessary for compliance with a legal obligation
4. Processing is necessary in order to protect the vital interests of the data subject or another person
5. Processing is necessary for the performance of a task carried out in the public interest
6. Processing is necessary for the purposes of the legitimate interests pursued by the data controller or by a third party
7. consent must be freely and clearly given by the individual – opt-out boxes or pre-ticked opt-in boxes do not count as consent.

Question 26

What are the data subject rights

Answer 26

individuals have certain rights under GDPR, including the right to be informed of how their data is used, the right to access their data and the right to have their data deleted if there is no convincing reason to continue processing it.

Question 27

What is the accountability principle

Answer 27

The ‘accountability principle’ requires organisations to demonstrate that they comply with the data protection principles of the GDPR.

Question 28

How are employers required to demonstrate compliance to the accountability principle (5)

Answer 28

1. Implement comprehensive, proportionate governance measures
2. for example, enforce relevant policies, procedures and training
3. Keep relevant documentation of processing activities, including information outlining what data is held, the source of data and who data is shared with
4. Put into practice technical and organisational security measures to prevent breaches and protect data
5. including appointing aData Protection Officer (DPO)

Question 29

How is the GDPR regulated and enforced (3)

Answer 29

1. In the UK, the GDPR is enforced by the Information Commissioner’s Office (ICO).
2. The ICO has the power to ensure that both individuals and organisations comply with data protection laws.
3. Organisations that breach the GDPR may be fined.