If you are a distance-selling pharmacy attached to a private high street-based, pharmacy, the GPhC may want to inspect your premises to ensure that you are not offering face-to-face NHS essential services to the public. In this case, a risk assessment of P medicine sales would be essential. Creating one requires a deep understanding of the local regulations, pharmacy operations, and the specific risks associated with the sale of Pharmacy Only (P) medicines. Here’s a simplified outline to guide you:

1. Identification of Risks:
   • Expiry date check
   • Incorrect Dispensing
   • Pharmacist Sale Approval
   • Miscommunication about medicine usage
   • Adverse reactions or interactions
2. Analysis of Risks:
   • Likelihood of occurrence
   • Potential impact
3. Evaluation of Risks:
   • Tolerability
   • Priority for addressing
4. Mitigation Strategies:
   • Staff training and certification
   • Clear procedures for the sale of P medicines
   • Patient counseling
   • Proper signage and information
   • Systems for verifying patient details and medicine details
5. Monitoring and Review:
   • Regular audits
   • Feedback collection from staff and patients
   • Review of adverse incidents
6. Documentation:
   • Recording all identified risks, analysis, mitigation strategies, and reviews
7. Compliance with GPhC Standards:
   • Ensuring all processes comply with the General Pharmaceutical Council (GPhC) standards and other relevant regulations.

This outline is quite general and should be tailored to the specific circumstances of the pharmacy in question. Consulting with a legal professional or a pharmacy consultant with experience in UK regulations is advisable for a thorough risk assessment. If you would like to get in contact with one please drop us a line.

Selling GSL (General Sales List) and P (Pharmacy) medicines online carries various risks and require careful consideration to ensure the safety and well-being of customers. This risk assessment aims to identify potential hazards and outline measures to manage or mitigate risks associated with selling GSL and P medicines online.

Identifying Hazards

• Incorrect use: Customers may purchase GSL and P medicines without consulting a healthcare professional, leading to incorrect use and potential harm.
• Misinformation: Customers may receive incorrect or misleading information about the use and dosage of medicines.
• Data breaches: Personal and medical information of customers may be at risk of being compromised in the event of a data breach.
• Counterfeit medicines: The sale of counterfeit GSL and P medicines may lead to serious health consequences for customers.
• Inappropriate supply: Medicines may be supplied to customers who do not meet the criteria for use, leading to inappropriate use.

Assessing the Risks

• Incorrect use: The risk of incorrect use can be mitigated by ensuring that customers have access to appropriate information and advice before purchasing medicines. This can be achieved by requiring customers to complete a questionnaire or consultation with a healthcare professional before being able to purchase GSL and P medicines.
• Misinformation: The risk of misinformation can be managed by ensuring that all information provided to customers is accurate and up-to-date. This can be achieved by ensuring that information is reviewed regularly and that customers are able to access information from reputable sources.
• Data breaches: The risk of data breaches can be mitigated by ensuring that appropriate measures are in place to protect customer data. This can be achieved by implementing appropriate security measures, such as encryption and access controls, and ensuring that staff are trained in data protection.
• Counterfeit medicines: The risk of counterfeit medicines can be managed by ensuring that medicines are sourced from reputable suppliers and that appropriate checks are carried out to ensure that medicines are genuine.
• Inappropriate supply: The risk of inappropriate supply can be mitigated by ensuring that customers are required to complete a questionnaire or consultation with a healthcare professional before being able to purchase GSL and P medicines. This will help to ensure that medicines are only supplied to customers who meet the criteria for use.

Risk Management Plan

• Establish appropriate protocols for customer consultations, including the provision of accurate and up-to-date information about the use and dosage of medicines.
• Ensure that all information provided to customers is accurate and up-to-date and is reviewed regularly.
• Implement appropriate security measures to protect customer data, including encryption and access controls.
• Source medicines from reputable suppliers and carry out appropriate checks to ensure that medicines are genuine.
• Require customers to complete a questionnaire or consultation with a healthcare professional before being able to purchase GSL and P medicines.

Conclusion

Selling GSL and P medicines online carries various risks that must be managed to ensure the safety and well-being of customers. By implementing appropriate risk management measures, these risks can be managed or mitigated effectively. It is important to ensure that all staff are trained in risk management and that risk assessments are reviewed regularly to ensure that they remain up-to-date and effective.

A full guaranteed, extended version of this document can be purchased here.

COVID Vaccine Clinic Standard Operating Procedures including:

• COVID-19 Pharmacy Vaccination Services
• COVID-19 Social Distancing and Infection Control Risk

Prescribing Specific Standard Operating Procedures including:

• Referral Criteria Policy
• Chaperoning Policy
• Safeguarding and protecting people from abuse policy (adult protection/child protection)
• Privacy, dignity and respect of service users
• Medication policy (dispensing process)
• Information management policy
• Infection prevention and control
• Participation policy
• Complaints policy
• Duty of Candour policy
• Recruitment and induction policy
• Staff training and development policy
• Bullying and harassment policy
• Whistleblowing policy
• Equality and Diversity Policy
• Clinical governance policy
• Staff Handbook

Health and Safety SOP list:

• Fire Risk Assessment
• Arrangements for dealing with emergencies including resuscitation
•  

Supplying Specific Products Standard Operating Procedures including:

• Supply of Insulin
• Supply of Lithium
• Supply of Methotrexate
• Supply of Oral Anticoagulant Medication
• Supply of Paraffin Based Skin Products
• Sale and Supply of Veterinary Medicines
• Supplying Oral Anti-Cancer Medicines

Information Governance Standard Operating Procedures including:

• Summary Care Records Privacy Officer

• Staff Confidentiality Agreement
• IG Policy
• Code of Conduct for Employees in Respect of Confidentiality
• Data Handling Procedures
• Mobile Computing Guidelines
• Information Security Incident Management
• Access Control and Password Management Procedure
• Ensuring Staff Compliance with RA01 Terms Template SOP
• GDPR Privacy notice for employees workers and contractors UK
• Privacy Statement for GDPR

Staff Induction Standard Operating Procedures including:

• Locum Induction
• Staff Induction

Signposting Standard Operating Procedures including:

• Signposting

Private Services Standard Operating Procedures including:

• Salbutamol Supply to Schools

• Blood Diagnostics via Finger Prick
• Dispensing Private Prescriptions

Operational Pharmacy Standard Operating Procedures including:

• Cleaning
• Cold Chain Maintenance
• Equipment Maintenance
• Health and Safety – Risk Assessment

Internet Pharmacy or Distance Selling Pharmacy Standard Operating Procedures including:

• Dispatching an Internet Order
• Final Checking an Internet Order
• Providing Services via an Internet Pharmacy
• Overarching Internet Pharmacy
• Preparing an Internet Order
• Receiving and Internet Order
• Setting up an internet pharmacy in the UK
• Pharmacy Social Media
• Cold Chain Delivery
• Selling OTC or P Medicines Online
• Pharmacy Cybersecurity

Checking NHS Standard Operating Procedures including:

• Taking an NHS Prescription Charge
• Remote Appliance Fitting
• Remote Compliance Aid Need Assessment
• Remote Patient Assessment of Repeat Dispensing Need
• Remote Promotion of Healthy Lifestyle and Public Health Campaigns
• Remote Signposting
• Remote Disposal of Medicines
• Remote Support for Self-Care
• Essential Services
• Accuracy Check by an Accredited Checking Technician
• Accuracy Checking
• Assembling and labelling prescriptions
• Chaperoning
• Date Checking
• Delivery of Medicines
• Dispensing Medicines with a Compliance Aid
• Dispensing of Prescriptions
• Disposal of Unwanted or Waste Medicines
• Electronic Prescription Service Release 2
• Emergency Supply
• End-of-Month Procedures
• Owing Medication Supply
• Prescription Collection Service
• Promotion of Healthy Lifestyle
• Receiving Stock into the Pharmacy
• Roles and Responsibilities of Pharmacy Staff
• Support for People With Disabilities (Disability Act 2010)
• Support for Self Care
• Uncollected Prescriptions
• Responsible Pharmacist
• Sale of Medicines
• Repeat Dispensing

Errors, Interventions and Complaints Standard Operating Procedures including:

• Complaints, Concerns, Enquiries and Compliments Procedure

• Dealing with Dispensing Errors
• Interventions and Problem Solving
• Near Miss Audit
• Pharmacy Patient Safety Incident Report and Follow Up
• Preventing errors and recording near misses

Enhanced Services Standard Operating Procedures including:

• Blood Glucose Monitoring

• Monitoring Blood Pressure
• Cardiovascular Screening
• Chlamydia Testing
• Cholesterol, Glucose, Hemoglobin Point of Care Testing
• Emergency Hormonal Contraception
• Hosiery Fitting
• Minor Ailments Scheme
• Monitored Dose Systems
• Needle and Exchange Service Scheme
• Palliative Care Enhanced Service
• Pharmacy Urgent Repeat Medicine Service
• Smoking Cessation

Controlled Drugs Standard Operating Procedures including:

• Balance Check and Record-Keeping
• Delivering Controlled Drugs Standard Operating Procedure
• Destruction of Controlled Drugs
• Dispensing Codeine and Dihydrocodeine
• Dispensing of Controlled Drugs
• Dispensing Supervised Methadone
• Extemporaneous preparation of methadone
• Instalment dispensing of Controlled Drugs
• Recording Concerns over CD management
• Security and Storage of Controlled Drugs
• Supervised Controlled Drugs
• Supply of Sativex

Business Continuity Standard Operating Procedures including:

• Operating in the Absence of a Responsible Pharmacist
• Pandemic Protocol
• Business Continuity Plan
• COVID Social Distancing and Infection Control Risk Assessment Tool

Advanced Services Standard Operating Procedures including:

• Appliance Use Reviews

• Medicine Use Reviews
• New Medicine Service
• Stoma Appliance Customisation Service
• DMIRs
• Seasonal Vaccine Clinics
• Infection Control
• Influenza Vaccination
• Needlestick Injuries and Contamination
• Travel Clinic
• Malaria Chemoprophylaxis
• MMR Vaccination
• Shingles Vaccination
• Travel Core
• Yellow Fever Centre

Esketamine mechanism of action

The exact mechanism by which esketamine works to relieve depression symptoms is not fully understood, but it is thought to involve changes in brain chemistry and the activity of certain neurotransmitters.

One possible mechanism is that Esketamine works by inhibiting the reuptake of the neurotransmitter glutamate in the brain. Glutamate is involved in the regulation of mood and behavior, and inhibiting its reuptake leads to an increase in its concentration in the brain. This increase in glutamate is thought to be responsible for the rapid antidepressant effects of esketamine.

In addition to its effects on glutamate, esketamine is also believed to have an effect on other neurotransmitter systems in the brain, including dopamine and norepinephrine. It is not fully understood how these additional mechanisms contribute to the antidepressant effects of the drug.

The Role of Esketamine in a Comprehensive Depression Treatment Plan

Esketamine is typically reserved for patients who have not responded to other treatments for depression and is used on an as-needed basis in conjunction with regular therapy sessions. It is not intended to be used as a standalone treatment for depression, but rather as a part of a comprehensive treatment plan that may include other therapies such as cognitive-behavioral therapy, psychotherapy, and/or medication management.

The role of esketamine in a comprehensive depression treatment plan is to provide rapid symptom relief for patients who have not responded to other treatments. It is usually used in combination with other therapies in order to help patients achieve and maintain symptom improvement over the long-term. It is important for patients to work closely with their healthcare team to develop a treatment plan that is tailored to their specific needs and goals.

1. Use a third-party age verification service: There are companies that specialize in age verification for online transactions. These services typically use databases of government-issued identification documents (such as driver’s licenses or passports) to verify the age of the customer. For more information on this have a look at our article on internet pharmacy id verification.
2. Require the customer to provide proof of age: Some online pharmacies may require the customer to upload a copy of a government-issued ID or other documentation as proof of their age.
3. Use age gates: An age gate is a page on the website that requires the visitor to confirm that they are of legal age to purchase the products being offered. This can be done by requiring the visitor to enter their date of birth or by using a third-party age verification service.
4. Use machine learning algorithms: Some online pharmacies use machine learning algorithms to analyze the customer’s behavior on the website and determine their age based on their actions.

It is important to note that each country has its own laws and regulations regarding age verification for online transactions, and online pharmacies should ensure that they are complying with all applicable laws.

Prescribing frameworks can vary depending on the healthcare setting and the type of medication being prescribed. For example, a hospital may have a different prescribing framework than a primary care clinic, and different frameworks may be in place for prescribing controlled substances compared to non-controlled medications. Prescribing frameworks may be developed by professional organizations, regulatory bodies, or government agencies, and may be based on evidence-based guidelines or best practices in the field.

Frameworks are primarily constructed from an audit of practice, which creates a risk mitigation matrix which then leads to a restriction of practice by the utilisation of standard operating procedures alongside a prescribing formulary.

The objectives of an online prescribing audit may include:

• Assessing the safety and effectiveness of the online prescribing process
• Evaluating the compliance of the online prescribing process with relevant laws and regulations
• Identifying any potential risks to patient safety or quality of care
• Making recommendations for improving the online prescribing process

During an online prescribing audit, the auditor may review the policies and procedures that are in place for prescribing medications online, as well as the systems and tools that are used to facilitate the prescribing process. They may also review records and data related to online prescribing, and may conduct interviews with relevant staff and stakeholders. The findings of the audit may be used to identify any areas of concern or improvement, and to develop recommendations for improving the online prescribing process.

We offer professionally written, high-quality template packages for conducting an online prescribing audit. Below is a simple excerpt from the package:

Methodology

Population:                              Users of the website: www.yourwebsitename.com

Sampling:                                  Ten prescriptions and associated documents should be selected or more if required

Frequency of Audit:          As determined by health service providers audit process for prescribing practice and medicine management

Method:                                     This is a retrospective audit

Part 1: Demographic Details

Part 2: Audit Tool

Part 3: Audit Tool for Prescription Writing for MDA Schedule 8 Medicinal Products

Calculation of Compliance Rate Percentage

The audit tool calculates the score for the audit. The score, expressed as a percentage, is calculated by dividing the number of “yes” answers by the total of “yes” and “no” answers. “Not applicable” answers are excluded from the calculation of the percentage score.

Example:

If there are 18 “yes” and 2 “no” answers, the score is calculated as follows:

18 (yes answers) divided by 20 (total of yes and no answers) multiplied by 100. The score in this example would be 90%.

There are several types of pharmacy audits:

1. Compliance audits: These audits are conducted to ensure that a pharmacy is following all relevant laws, regulations, and policies related to the practice of pharmacy.
2. Quality assurance audits: These audits are designed to evaluate the quality of pharmacy services and to identify areas for improvement.
3. Clinical audits: These audits focus on the clinical aspects of pharmacy practice, including the accuracy and appropriateness of medication orders and the quality of patient care.
4. Financial audits: These audits are conducted to assess the financial performance and efficiency of a pharmacy.
5. Information systems audits: These audits evaluate the security and effectiveness of a pharmacy’s computer systems and technology.
6. Supply chain audits: These audits examine the processes and systems used by a pharmacy to purchase, store, and dispense medications.
7. Safety audits: These audits assess the safety of a pharmacy’s facilities, equipment, and processes.

Audits may be conducted by external organizations such as regulatory agencies or professional bodies, or by the pharmacy itself as part of an ongoing quality improvement process.

Pharmacy Audit Examples

Here are a few community pharmacy audit templates you can download and reuse as you wish:

• Community Pharmacy Audit Template on NSAID Audit on Gastrointestinal Safety
• Community Pharmacy Audit Template on LABA as monotherapy for the treatment of asthma without ICS preventer treatment
• Community Pharmacy Audit on Hydration Messages to Prevent Acute Kidney Injury
• Community Pharmacy Audit Template on Opioid Replacement Therapy
• Community Pharmacy Audit Template on Emergency Hormonal Contraceptives
• Community Pharmacy Audit Template on Valproate Safety
• Community Pharmacy Self-Audit Checklist
• Community Pharmacy Audit Template on Antibiotics
• Community Pharmacy Audit Template on Gabapentin and Pregabalin

You can perform an audit yourself, or delegate this task to another appropriately qualified professional, however, why not let us help? In our online store, we offer an easily downloadable pharmacy audit template pack.

There are some exceptions to this rule, such as in the case of telemedicine, where a healthcare provider may prescribe controlled substances via a video call if certain conditions are met. However, the use of psychedelics for medical purposes is still highly regulated and not widely accepted.

One recent example of poor online prescribing practice is a story of a patient who was prescribed 75 doses of Ketamine in 5 minutes online which was then delivered to his house for under $300. Whilst providing access to low-cost medicine for patients is an ethical virtue of practice one should keep in mind that there is an online prescribing best practice which should be followed. This includes online prescribing risk analysis and subsequent mitigation which should be performed after each medicine is added to an online prescribing formulary.

However, if proper safeguards are in place there are a wide range of opportunities in the medical space, including:

• Psilocybin availability in the UK

If you would like more information concerning these opportunities you can contact one of our expert consultants here.

The best way to best avoid inappropriate orders is to filter patients through exclusion inclusion criteria and formulate an individual risk profile for each patient using a combination of online prescribing risk matrixes and algorithmic risk formularies.

To reduce multiple orders of specific products, see below, we have coded a patient protection algorithm into our ordering system to ensure multiple high-risk medicines cannot be purchased within one order.

• Paracetamol / acetaminophen – a common medicine used in suicide.
• Pseudoephedrine – methamphetamine conversion risk.
• Dextromethorphan – opioid abuse potential.
• Pholcodine – opioid abuse potential.
• Promethazine – sedative abuse.
• Laxatives – weight loss.

Do you need a pharmacist consultant to help you with your governance to ensure you meet the regulations? Look no further, contact us here.