Study design
This involved both cross-sectional and interventional study designs. Cross sectional surveys of selected hospital pharmacies was conducted at baseline (pre-intervention) and then repeated after at least 12 months post-intervention. The baseline assessment of the pharmacy systems and services was conducted to identify site specific gaps for targeted interventions.
Settings
The study setting included primary, secondary and tertiary health facilities in Nigeria. There are three levels of public health care in Nigeria – primary, secondary and tertiary, which are owned and managed by Local Government Authorities, State Government and Federal Government of Nigeria respectively. These 3 levels of health care are connected through a referral system. The GHAIN project supported secondary and tertiary health facilities to offer comprehensive HIV care services including both antiretroviral therapy (ART) and prevention of mother to child transmission of HIV (PMTCT) or just PMTCT stand-alone services. The primary health facilities were supported to provide mainly PMTCT stand-alone services. All the health facilities have a distinct pharmacy department responsible for providing pharmaceutical services to the patients.
Population and sample
The population for the study sites included 184 health facilities supported by GHAIN project spreading across all 36 states plus Federal Capital Territory of Nigeria. Sixty health facilities were selected from this population for the post-intervention assessment using simple random sampling technique.
Inclusion/exclusion criteria
All health facilities that had record of the pre-intervention assessment of the hospital pharmacies, provided HIV care services to HIV-infected persons for ≥12 months’ duration of post-intervention and supported by GHAIN project were included in this assessment. All health facilities that which did not meet these criteria were excluded from the study.
Interventions
HU-PACE strategies for achieving its mandate in GHAIN project involved sensitization and mobilization of relevant members of the Pharmaceutical Society of Nigeria (PSN), the Pharmacists Council of Nigeria (PCN), the National Institute for Pharmaceutical Research and Development (NIPRD), the National Agency for Food and Drug Control (NAFDAC) and the Food & Drugs Division of Federal Ministry of Health through a launch of the pharmacy component of GHAIN.
Other interventions included the provision of standards for infrastructural upgrade of the pharmacy environment such as the renovations of counselling rooms to guarantee audio-visual privacy; provision of standards for appropriate drug storage such as lockable cupboards, shelves and pallets, refrigerators, wall and fridge thermometers and functional air conditioning. The interventions also included the development of a curriculum and modules for a training of pharmacists and lower cadre pharmacy personnel as needed; development and provision of required job aids and tools, and conduct of centralized didactic trainings prior to the activation of facilities for service provision.
A follow-up onsite skill enhancement to ensure application of knowledge and skills in service provision and accurate documentation was conducted at the inception of HIV comprehensive services through a hands-on training of the pharmacy staff on selected elements of pharmacy best practices using Pharmacy State Coordinators who are recognized leaders in the Nigerian pharmacy community. This role was later transitioned to State Directors of Pharmaceutical Services (DPS) who are responsible for maintaining the standards of pharmacy practice in Nigeria. Training modules developed for pharmacists included all components of HIV pharmaceutical care, clinical pharmacovigilance of ARV drugs, and pharmacy best practices elements focusing on dispensing, patient counselling, refilling, patient adherence, referral process, education programs, interaction with other health team members, data production and collection and control of drugs. In addition, a level adjusted curriculum focusing on drug dispensing and documentation for HIV/AIDS services was developed for lower cadre pharmacy and support personnel within primary, secondary and tertiary level of care.
Tools developed for documentation of pharmaceutical care services and for drug inventory control included the pharmacy order form for prescription ordering, pharmaceutical care daily worksheet for daily documentation of pharmaceutical care provided to clients including the screening and documentation of drug therapy problems and the interventions in the pharmacy; pharmacy daily worksheet for daily documentation of prescription orders filled in the pharmacy; monthly work books, and monthly summary forms, pharmacy appointment diaries, and patient status registers. The National Individual Case Safety Report Form was deployed for reporting of suspected ADRs to the National Pharmacovigilance center, National Agency for Food, Drug Administration and Control (NAFDAC). Some IEC materials and job aids provided were dispensing trays, auxiliary medication labels with label key charts, key to grading adverse drug reactions, plain medication labels, pharmacy jackets, and pharmacists’ tags.
To overcome the acute shortage of pharmacists at the project pharmacies amidst increasing patient load and associated documentation, GHAIN conceptualised and set up the HU-PACE Pharmacists Volunteer Scheme (HPVS). The HPVS provides trained volunteer hospital and community pharmacists as added resource to support hospitals with high patient load to provide HIV related pharmaceutical services at their convenience while serving as a pool of skilled pharmacists who can provide HIV pharmaceutical care at their primary places of practice.
Sustainability strategies that was implemented include the training of all states government employed Directors of Pharmaceutical Services who have the primary responsibility for providing oversight to these hospital pharmacies. They were trained on Pharmaceutical care in HIV/AIDS and Pharmacy Best Practice elements to build their capacity in providing technical supervision. They were also involved in the hands-on pharmacy best practices training of health facility staff, joint monitoring and supportive supervisory visits with project personnel and the conduct of bimonthly peer-review and feedback meetings. The pharmaceutical care data generated from all supported facilities in each state were also reviewed for any emerging trends at this meeting. The project also collaborated with the Pharmacist Council of Nigeria to incorporate project training modules into the curriculum for mandatory continuing professional development for pharmacists in Nigeria. In collaboration with NAFDAC and the National Drug Safety Advisory Committee, resource materials on Clinical Pharmacovigilance of ARV drugs was developed and disseminated.
Service package for HIV-positive clients
Following the interventions, the HU PACE supported service package for HIV-positive clients at the health facilities included routine medication adherence counselling for pre-ART, ART, and PMTCT patients; screening and reporting of medication errors; screening and reporting of adverse drug reactions; resolution of potential or actual drug therapy problems; and drug inventory management. Patient-focused dispensing information covers the medication use information, drug regimen, adherence, drug storage, possible interactions, adverse effects and cautionary measures amongst others.
Data collection
The data collection was done using a project-specific pharmacy interview guide. The key sections of the guide included human resources and staff capacity, interaction between pharmacist and clients, infrastructure, availability of drugs, logistics, guidelines and procedures. The interview guide was used by the researchers and the trained assistants to elicit responses from the participants on the questions items. Other methods used for data collection included direct observations and review of records. Management approval was obtained from the management of the hospitals. Ethical exemption was obtained from Health Research Ethics Committee, Abuja Nigeria. Informed consent was also obtained from the participants. The respondents consisted of facility pharmacists or a pharmacy staff who is very knowledgeable about the project pharmacies.
Monitoring and evaluation
Continuous quality improvement was ensured by Monitoring and Evaluation Pharmacists through routine monitoring and supportive supervision using pharmacy practice log, service quality assessment checklist and periodic data verification and collation in the pharmacy. In addition, GHAIN initiated periodic performance review and feedback meetings of stakeholders led by State Directors of Pharmaceutical Services (DPS), to jointly address quality related issues. Quality improvement measures were implemented throughout the life of the project and included retraining as appropriate, to provide updates and share new concepts, providing support to initiate or strengthen existing Medicine and Therapeutic committees and ARVs Pharmacovigilance sub-committees within the hospitals.
The Predictive Analytical SoftWare (PASW®) was used for data analysis. Descriptive statistics was used to describe the key variables of interest. Chi-square was used for inferential statistics. All reported p-values were 2-tailed at 95% confidence interval.