College Contact: Pharmacy Practice
Multi-medication compliance aids offer a safe and effective approach to managing medication therapy by placing different medications in the same compartment, organized by dosing intervals. They are appropriate for patients who have difficulty remembering to take medications correctly, but who are otherwise deemed capable of self-administration or for those with complex drug regimes when other methods to improve compliance have been unsuccessful.1 Some of the benefits of this approach to treatment include:
- Effective treatment of a condition requiring multiple medications through optimal dosing and incorporation of several medications (prescription and non-prescription) in one place;
- Better clarity and transparency of treatment through more effective communications between health professionals and patients; and
- Improved drug utilization while minimizing waste.
The decision to use a multi-medication compliance aid is made by the pharmacist in collaboration with the patient, family member/caregiver and prescriber where there is a clear benefit to the patient of using this approach. The pharmacist will only provide compliance packaging to patients if he or she has the necessary knowledge and skills to provide this service. The pharmacy must have policies and procedures in place, and the appropriate physical space, equipment and trained staff to ensure the safe preparation of compliance packages.
Compliance packaging is available in various formats including single medication blister cards, multi-medication blister cards, hard packs, and strip packaging. The pharmacist will evaluate whether the medication is suitable for compliance packaging, including a consideration of any drug interactions and the impact of the packaging process itself on the medication. The choice of packaging material will also be determined by the physical and chemical characteristics of each drug, and potential response to temperature fluctuations, light, moisture, and method of packaging. In addition, registrants must take into consideration best practices for drug administration when packaging a compliance aid. For example, medications that require administration on an empty stomach (e.g. bisphosphonates) should be packaged separately from other medications, and medications administered on an “as required” basis are generally unsuitable for packaging in a compliance aid since they may be mistakenly taken on a regular basis. If in doubt about the suitability of a drug for inclusion in a compliance pack, the registrant should contact the manufacturer.
Medications in compliance aids must be packaged as soon as possible after being removed from the stock bottle to minimize atmospheric exposure and protect the integrity of the medication. Sanitary procedures must be implemented to prevent staff from having direct contact with the drugs, for example by using gloves or tweezers, along with frequent hand washing. The pharmacy must have a protocol in place to check that the contents of the compliance package match the prescriber’s order. If using optical scanner technology, the equipment should be tested and calibrated to ensure it is in proper working order. Once products are packaged, they are to be stored under the appropriate conditions until dispensed, i.e. packages containing temperature sensitive medications must be placed in the refrigerator in order to maintain the cold chain.
Dispensing a Multi-Medication Compliance Aid
The medications used in the compliance aid are to be dispensed for the entire prescribed quantity, unless otherwise indicated by the patient or prescriber.(2) The quantities of “PRN” medications are established in collaboration with the prescriber and patient and should be dispensed in a separate container. The patient or his or her agent must give written consent to dispense the patient’s medication in a multi-medication compliance aid, including a note that the compliance aid may not be child resistant, if relevant. It is recommended that consent be reviewed on a yearly basis and updated as required. The compliance aid is to be modified promptly when changes are made to the patient’s drug therapy regimen. Medications which are returned to the pharmacy cannot be re-dispensed to another patient: however, the registrant may accept the return of medications for repackaging for the same patient where a change in therapy has occurred. If the registrant relies on his or her independent authority to renew or adapt a medication contained within the compliance aid, the registrant must notify the prescriber and update the consent and treatment plan, including the clinical rationale for the change as outlined in the College’s Initiating, Adapting and Renewing Prescriptions.
All container identification markings required by legislation apply to compliance packages.(3) Labeling includes the information that would appear if each drug had been dispensed in individual vials, in addition to a description of the shape, and colour of the tablet or capsule in a manner that meets the needs of the patient. The label indicates the dosing specifications for each medication, including day and time, with an emphasis on those medications that are taken at different frequencies, i.e. bisphosphonates. Each package is sequentially numbered where appropriate.
Documentation and Record-Keeping
All details of the program will be documented, including disclosure of any charges and details of reimbursement. Documentation and record-keeping will be completed according to the standards established in OCP Documentationand Record Retention, Disclosure, and Disposalguidelines. The pharmacy must have a process in place to record changes in dispensing to mitigate potential data errors when switching from regular to compliance dispensing. Documentation must also reflect any additional changes, including for example, switching the frequency of dispensing, administration, and dosage changes based on the patient’s response to therapy. Where changes are initiated by the prescriber, a scanned electronic copy of the prescription is to be maintained in the pharmacy system. Changes may also be noted on the hard copy of the dispensing record and scanned back into the system. A summary of the information that should be reviewed to support the initiation of a multi-medication compliance aid program is attached (Appendix 1)
- Brent National Health Service, Teaching Primary Care Trust, Policy for the Use of Medicine Compliance Aids
- Drug Interchangeability and Dispensing Fee Act, Section 9.1.
- Drug and Pharmacies Regulation Act, 1990, Section 156(3)
Summary Information – Multi-Medication Compliance Aid Program
The decision to use a multi-medication compliance aid is made by the pharmacist in collaboration with the patient, family member/caregiver and prescriber. The information to be shared between the parties in setting up this dispensing option includes, for example:
- Direction on ordering routines and prescription delivery/pick-up;
- Acknowledgement that prescriptions are being dispensed in non-child safe packaging, if relevant;
- Patient consent for pharmacist to access test results ordered by the physician related to prescribed drug therapy;
- Acknowledgement/outline of the pharmacy’s “take back” program (to monitor compliance);
- Emergency contact numbers (family, caregiver, etc.);
- Approval/acknowledgement of the addition of non-prescription drugs into compliance aid; and
- Details on the issuance of receipts and other billing details, including information about third-party billing (if applicable).
- The condition/rationale for dispensing medications in a compliance aid;
- Acknowledgement/direction for any reductions in quantities dispensed and
- The number of doses to provide for PRN drugs (e.g. analgesics, sleep aids, etc.), creams and liquids.
Pharmacist: This section should outline what the patient can expect from the pharmacist:
- Pick-up and delivery times;
- Child proof or not;
- Destruction of drugs and retention of personal health information;
- Quality assurance procedures, use of gloves, checking of meds, review of program;
- MedsCheck evaluations, how many or how often;
- Consultation with physicians/prescribers; and
- Any reports that pharmacist could provide (if applicable.)