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Pharmacy Practice and Pharmaceutical Sciences Risk Assessment: Medication Safety, Controls and Continuity

A worked example of how a community dispensary identifies, scores and controls risks to medicine safety, stock integrity, patient privacy, staffing and continuity of supply and service.

Updated November 2026 8 hazards assessed Review every 6 months Highest risk: Critical to Medium
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Executive summary

This assessment shows how a community pharmacy can find, rate and control the risks that matter most to patient safety, medicine integrity and continuity of service. Eight risks were chosen because they are plausible in everyday dispensing, counseling and stock work. Dispensing error is the most serious inherent risk, and it is reduced most by barcode checks, sampling and a clear reporting habit. Controlled drug discrepancy, cold chain failure, privacy breach, staffing gaps, system failure, supply shortage and exposure to hazardous drugs also appear. Each risk is scored before controls and again after existing and added controls. Most risks fall to Medium or Low once the added controls are in place, but supply disruption and staffing gaps remain Medium because they depend on factors outside the pharmacy. The first actions are barcode scanning, a controlled drug reconciliation routine, a fridge alarm check and a named cover plan for each shift. The pharmacy is a teaching example, so every score illustrates the method, not a real organization.

Focus area
Pharmacy practice and pharmaceutical sciences
Setting
Community pharmacy dispensing and patient counseling service with supporting stock management and compounding
Method
Five by five likelihood and impact risk register

Scope

This assessment covers a community pharmacy's dispensing, storage, counseling, stock and record keeping processes, from prescription receipt to handover of medicines to patients. It looks at risks to patients, staff, medicines, records and the pharmacy's continuity of service. It does not cover hospital pharmacy, clinical trials or any real premises. Jurisdiction, pharmacy size, dispensing software and supplier arrangements are assumptions made for teaching.

Context

The pharmacy has a superintendent-level pharmacist, several registered pharmacists, dispensing assistants, a counter team and a delivery driver. Prescriptions arrive electronically and on paper, and dispensing is recorded in a pharmacy management system linked to a wholesale supplier. Controlled drugs, cold chain products and high-risk medicines need extra checks. Each risk is scored before controls to show its natural level, then again after the existing controls and the additional controls that should be added.

Objectives, assets and stakeholders

The objective is to supply safe and correct medicines, keep controlled and cold chain stock accurate, protect patient records, maintain staffing and continuity, and keep the trust of patients, prescribers and regulators. The assets in scope are medicine stock, controlled drug records, patient records, dispensing equipment, refrigerators, the pharmacy management system and the professional reputation of the team. Stakeholders include patients and carers, pharmacists and dispensing staff, prescribers, wholesale suppliers, the data protection lead, occupational health services and the regulator. Clear roles matter: every risk has one owner role, and the superintendent pharmacist reports the register to the owner group each quarter.

Risk matrix: before and after controls

Each cell shows hazard numbers placed by likelihood and impact. Compare the two grids to see how controls move each hazard.

Before controls

Inherent risk

Risk before controls: rows are likelihood from almost certain to rare, columns are impact from insignificant to catastrophic. Cells list hazard numbers.
1
Insignificant		 2
Minor		 3
Moderate		 4
Major		 5
Catastrophic
5 Almost certain Likelihood 5, impact 4, score 20, critical: H01
4 Likely Likelihood 4, impact 3, score 12, high: H05
3 Possible Likelihood 3, impact 3, score 9, medium: H06 Likelihood 3, impact 4, score 12, high: H02 H03 H04 H07
2 Unlikely Likelihood 2, impact 5, score 10, high: H08
1 Rare

After controls

Residual risk

Risk after controls: rows are likelihood from almost certain to rare, columns are impact from insignificant to catastrophic. Cells list hazard numbers.
1
Insignificant		 2
Minor		 3
Moderate		 4
Major		 5
Catastrophic
5 Almost certain
4 Likely
3 Possible Likelihood 3, impact 2, score 6, medium: H05
2 Unlikely Likelihood 2, impact 2, score 4, low: H06 Likelihood 2, impact 3, score 6, medium: H02 H03 H04 H07 Likelihood 2, impact 4, score 8, medium: H01
1 Rare Likelihood 1, impact 4, score 4, low: H08
  • Low 1 to 4
  • Medium 5 to 9
  • High 10 to 16
  • Critical 17 to 25

Hazard register

A summary first, then the detail for each hazard.

Summary of hazards with scores before and after controls
No.HazardBeforeAfterOwner
H01 Dispensing error reaching the patient 20 Critical 8 Medium Superintendent pharmacist
H02 Controlled drug records and stock discrepancy 12 High 6 Medium Responsible pharmacist
H03 Cold chain failure for temperature sensitive medicines 12 High 6 Medium Dispensary manager
H04 Breach of patient privacy and records 12 High 6 Medium Information governance lead
H05 Staffing gaps and poor handover 12 High 6 Medium Dispensary manager
H06 Failure of dispensing or information system at peak time 9 Medium 4 Low Information governance lead
H07 Supplier shortage or substandard product 12 High 6 Medium Procurement lead
H08 Exposure to hazardous drugs and infection during compounding and counseling 10 High 4 Low Infection prevention lead
H01

Dispensing error reaching the patient

Safety Before 20 After 8

The wrong strength, drug, quantity or label is supplied to a patient because a prescription is misread, a product is similar in name or appearance, or a check is skipped during a busy period.

Who or what is affected: Patients, carers, dispensing staff and prescribers

Causes

High workload, similar product names, handwritten prescriptions and interruptions at the counter.

Consequences

Patient harm, hospital admission, complaint, professional review and loss of public trust.

Existing controls

  • Each dispensed item is checked by a second dispenser or pharmacist before handover.
  • Look alike and sound alike products are flagged on the system.

Control gaps

Second checks are sometimes rushed, and no one reviews near misses across shifts.

Additional controls

  • Prevent: Use barcode scanning at the point of dispensing and block product changes without a pharmacist override.
  • Detect: Review a random sample of labels and counseling records each week against the prescription.
  • Respond: Contact the prescriber and patient at once when an error is found and record the event for review.
Likelihood 5 x impact 4 before; 2 x 4 after Owner: Superintendent pharmacist Target: Within 30 days Early warning: Two or more near miss reports for the same product within one month.
H02

Controlled drug records and stock discrepancy

Legal and compliance Before 12 After 6

Controlled drugs are received, supplied or destroyed without accurate records, so stock counts do not match the register and diversion or loss can go unnoticed.

Who or what is affected: Pharmacists, patients, regulators and the pharmacy owner

Causes

Shared access, rushed recording, unclear destruction procedures and pressure on counter staff.

Consequences

Regulatory action, loss of licence, patient harm from diversion and personal liability.

Existing controls

  • A controlled drug register is kept and checked against stock at each shift handover.
  • Only named pharmacists may sign for destruction of medicines.

Control gaps

Weekly checks are not always completed and access lists are not reviewed after staff changes.

Additional controls

  • Prevent: Restrict access to the controlled drug cabinet to named staff and remove access for anyone who changes role.
  • Detect: Run a weekly reconciliation of the register against physical stock and investigate any gap the same day.
  • Recover: Report losses to the relevant authority as the rules require and document the root cause.
Likelihood 3 x impact 4 before; 2 x 3 after Owner: Responsible pharmacist Target: Within 14 days Early warning: Any unexplained gap between the controlled drug register and physical stock count.
H03

Cold chain failure for temperature sensitive medicines

Operational Before 12 After 6

Refrigerated medicines are stored or delivered outside their required temperature range because a fridge fails, a door is left open or a delivery is held too long, so products lose potency.

Who or what is affected: Patients, dispensing staff and the supplier

Causes

Power cuts, equipment age, long dispatch times and staff leaving doors open.

Consequences

Reduced medicine effect, wasted stock, patient harm and costly replacement.

Existing controls

  • Fridge temperatures are logged twice daily by a named staff member.
  • A temperature alarm sends a message to the pharmacist on duty.

Control gaps

Alarm messages are not always received during evenings, and backup power has not been checked.

Additional controls

  • Prevent: Place refrigerated stock in a fridge with a backup power supply and keep a stock limit on the door shelf.
  • Detect: Check the logs against alarm history each week and review any reading outside the range.
  • Respond: Quarantine suspect stock and contact the supplier before any product is supplied.
Likelihood 3 x impact 4 before; 2 x 3 after Owner: Dispensary manager Target: Within 30 days Early warning: A fridge reading outside range or an alarm not acknowledged within 15 minutes.
H04

Breach of patient privacy and records

Technology and data Before 12 After 6

Patient records, prescription images or medicine histories are viewed, sent or left in view by people who do not need them, or are lost when a device is stolen or misdirected.

Who or what is affected: Patients, staff and prescribing practices

Causes

Shared terminals, curious staff, public counter conversations and unencrypted portable devices.

Consequences

Distress to patients, regulatory penalties, loss of trust and damage to the pharmacy's reputation.

Existing controls

  • Staff sign confidentiality terms and use individual log in details.
  • Screens are turned away from the public counter and locked when unattended.

Control gaps

Log reviews are not scheduled and portable devices are not all encrypted.

Additional controls

  • Prevent: Enable multi-factor sign in and restrict record access to staff with a working reason.
  • Detect: Review access logs each month and flag views of records with no linked dispensing event.
  • Respond: Notify affected patients and the data protection lead promptly when a breach is confirmed.
Likelihood 3 x impact 4 before; 2 x 3 after Owner: Information governance lead Target: Within 45 days Early warning: A record viewed by a user who has no dispensing or counseling link to that patient.
H05

Staffing gaps and poor handover

People Before 12 After 6

Staff absence or a short roster leaves no registered pharmacist on duty for a period, or information about a patient, a delayed order or an urgent change is not passed between shifts.

Who or what is affected: Patients, dispensing staff and pharmacists on duty

Causes

Sickness, holiday peaks, reliance on a few staff and unclear handover habits.

Consequences

Unsafe supply, missed clinical advice, poor staff morale and service closure.

Existing controls

  • A rota is planned four weeks ahead with cover named for each shift.
  • A handover book is used at the end of each shift.

Control gaps

Cover is arranged late and handover entries are often brief or missing.

Additional controls

  • Prevent: Set a minimum skill mix for each shift and stop dispensing high risk items when no pharmacist is present.
  • Respond: Use a locum agency or a pharmacist from a partner site and log the cover before the shift starts.
  • Detect: Review handover entries weekly and check that urgent items were closed.
Likelihood 4 x impact 3 before; 3 x 2 after Owner: Dispensary manager Target: Within 60 days Early warning: A shift planned with no registered pharmacist or with an open urgent handover item.
H06

Failure of dispensing or information system at peak time

Operational Before 9 After 4

The pharmacy management system, network or label printer fails during a busy period, so prescriptions cannot be checked, labeled or recorded and patients wait or leave without medicines.

Who or what is affected: Patients, dispensing staff and prescribers

Causes

Power or network outage, software updates and hardware faults.

Consequences

Delayed treatment, missed doses, dispensing errors during recovery and complaints.

Existing controls

  • A paper downtime form is kept at the counter.
  • The system is backed up each night by the vendor.

Control gaps

Downtime forms are seldom practiced and backups are not restored in a test.

Additional controls

  • Prevent: Keep a second internet link and test the paper downtime process each quarter.
  • Recover: Restore the system from the latest backup and reconcile paper records once service returns.
  • Respond: Tell patients and prescribers about delays and prioritize urgent and controlled items.
Likelihood 3 x impact 3 before; 2 x 2 after Owner: Information governance lead Target: Within 60 days Early warning: A system response time above the agreed limit for more than ten minutes.
H07

Supplier shortage or substandard product

Supplier Before 12 After 6

A key medicine is out of stock, is recalled or arrives with packaging or documents that do not match, so the pharmacy cannot supply a patient or must rely on an unverified alternative.

Who or what is affected: Patients, prescribers and the pharmacy owner

Causes

Global shortages, supplier failure, short notice changes and unverified sources.

Consequences

Missed treatment, unsafe substitution, product recall costs and trust loss.

Existing controls

  • Two wholesalers are approved and orders are placed on a daily schedule.
  • Incoming stock is checked against the invoice and batch number.

Control gaps

Buffer levels are set once a year and batch checks are not always recorded.

Additional controls

  • Prevent: Hold a minimum buffer for essential medicines and check each supplier's license before a new contract.
  • Detect: Subscribe to alerts about recalls and check each batch number against them before supply.
  • Respond: Contact the prescriber for a suitable alternative and record every substitution.
Likelihood 3 x impact 4 before; 2 x 3 after Owner: Procurement lead Target: Within 60 days Early warning: An essential medicine with less than five days of stock or a supplier shortage notice.
H08

Exposure to hazardous drugs and infection during compounding and counseling

Safety Before 10 After 4

Staff or patients are exposed to hazardous drugs, body fluids or infectious agents during compounding, waste handling or face to face counseling, because protective equipment is missing or hand hygiene is not followed.

Who or what is affected: Pharmacists, dispensing staff, cleaners and patients

Causes

Hazardous drugs in routine stock, cramped space, unclear waste routes and time pressure.

Consequences

Staff illness, long term health effects, patient infection and legal claims.

Existing controls

  • A safety cabinet is used for hazardous compounding and is certified before use.
  • Staff are trained in hand hygiene and personal protective equipment.

Control gaps

Cabinet checks are not dated and waste is sometimes stored in general bins.

Additional controls

  • Prevent: Use a closed system transfer device for hazardous preparations and provide protective equipment in every room.
  • Detect: Audit hand hygiene and protective equipment use each month with a short observation check.
  • Respond: Follow the exposure procedure, report the incident and arrange occupational health review the same day.
Likelihood 2 x impact 5 before; 1 x 4 after Owner: Infection prevention lead Target: Within 30 days Early warning: A missing protective item or an observed hand hygiene lapse during a monthly audit.

Rating method and evaluation

Each risk is rated on two five-point scales. Likelihood runs from Rare to Almost certain, and impact runs from Insignificant to Catastrophic. Multiplying the two gives a score from 1 to 25, which falls into one of four bands: Low from 1 to 4, Medium from 5 to 9, High from 10 to 16 and Critical from 17 to 25. The score is a guide for ordering work, not a measurement. Inherent risk is the score before any controls. Residual risk is the score after the existing and added controls. Impact is judged on harm to patients, legal exposure, time to correct, the effect on service and harm to trust, and a patient safety risk is never rated down only because it has not yet happened. Anything Critical or High needs senior attention and a dated plan, anything Medium needs routine controls with a named owner, and anything Low is accepted and watched. Pharmacists and dispensing staff should challenge the ratings, and each hazard is reviewed whenever an indicator reaches its threshold or after any near miss or incident. Specialist review is needed for any clinical judgment, and the scores do not replace a formal site-specific assessment.

Likelihood, impact and rating bands

Likelihood

  • 5 Almost certain: Expected to happen in most circumstances.
  • 4 Likely: Will probably happen in many circumstances.
  • 3 Possible: Could happen at some time.
  • 2 Unlikely: Not expected, but it could happen.
  • 1 Rare: Only in exceptional circumstances.

Impact

  • 1 Insignificant: No lasting effect. Handled within routine work.
  • 2 Minor: Small effect that is quickly corrected.
  • 3 Moderate: Noticeable effect that needs managed effort to correct.
  • 4 Major: Serious effect on people, delivery or reputation.
  • 5 Catastrophic: Severe or lasting effect that threatens the whole activity.

Bands (likelihood x impact)

  • Low (1 to 4): Accept and monitor.
  • Medium (5 to 9): Manage with routine controls.
  • High (10 to 16): Senior attention and a treatment plan.
  • Critical (17 to 25): Act first. Do not proceed until reduced.

Monitoring, escalation and review

Review this assessment every 6 months, and sooner when an indicator below reaches its threshold.

Early-warning indicators and escalation thresholds
Indicator to watchEscalate when
Dispensing near miss reports for the same product within one month.Escalate to the superintendent pharmacist when two or more reports occur for one product, and hold supply of that product until a check is made.
Any unexplained gap between the controlled drug register and physical stock.Escalate to the responsible pharmacist at once, and to the regulator as the rules require if the gap is not resolved the same day.
Fridge readings outside range or alarms not acknowledged within 15 minutes.Escalate to the dispensary manager at once, and quarantine affected stock until the supplier confirms it is usable.
Access log views of patient records with no linked dispensing or counseling event.Escalate to the information governance lead within one working day, and to the data protection lead if misuse is confirmed.
Shifts planned with no registered pharmacist or with open urgent handover items.Escalate to the superintendent pharmacist before the shift starts, and stop high risk dispensing if no cover can be found.

Contingency arrangements

If a serious event occurs, such as a dispensing error reaching a patient, a confirmed controlled drug loss or a data breach, the responsible pharmacist stops the affected supply, preserves records and informs the superintendent pharmacist. The prescriber and patient are contacted at once. The information governance lead isolates affected systems and restores data from the latest tested backup. Regulator and insurer contacts are made through the superintendent pharmacist as the rules require. Staff needing support are referred to occupational health, and patients receive clear, early and plain information.

Prioritized action plan

  1. Introduce barcode scanning and a pharmacist override log at dispensing, owner superintendent pharmacist, within 30 days.
  2. Start weekly controlled drug reconciliation and restrict cabinet access to named staff, owner responsible pharmacist, within 14 days.
  3. Test fridge alarms and back up power, and confirm alarm contacts for evenings, owner dispensary manager, within 30 days.
  4. Enable multi-factor sign in, encrypt portable devices and schedule monthly access log reviews, owner information governance lead, within 45 days.
  5. Set a minimum skill mix for each shift and a named locum route, owner dispensary manager, within 60 days.

Conclusion

Safe pharmacy practice depends on steady habits: second checks, scanned products, reconciled controlled drug records, monitored fridges, named cover for every shift, tested backups and protected records. The highest scores sit with dispensing error, and each has actions that bring the residual score down. Treat the register as a living record, review it on the stated cycle, and seek qualified professional and specialist advice for any real clinical, legal or regulatory question.

Assumptions and limitations

Assumptions

  • The pharmacy operates under one national or regional pharmacy regulator and its rules apply in full, though the exact rules are not specified here.
  • Staff are registered and trained for their roles, and the dispensing system is supported by a vendor.
  • Patients include adults and children, and some receive medicines that need counseling or monitoring.

Limitations

  • The scores are examples for learning and do not describe any real pharmacy, patient group or regulator inspection.
  • Medicine rules, storage requirements and professional duties vary by country and change over time, so specialist review is needed.
  • This is educational content and does not replace a formal site-specific assessment, clinical judgment or licensed professional advice.

Related frameworks to study

  • Hierarchy of controls
  • Failure mode and effects analysis
  • Root cause analysis
  • Three lines model of risk ownership
  • Structured clinical incident review

Healthcare Risk Assessment

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For Learning Reference Only: This assessment demonstrates how risk assessment principles are applied in a practical setting, providing a useful reference for learning and understanding. Actual assessments may be adapted to suit specific site conditions and circumstances.

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